fluorouracil
Trade name: efudex
Small moleculeapproved
Approved
Apr 25, 1962
Fluorouracil is an antineoplastic anti-metabolite. Anti-metabolites masquerade as purine or pyrimidine - which become the building blocks of DNA. They prevent these substances from becoming incorporated into DNA during the "S" phase (of the cell cycle), stopping normal development and division. Fluorouracil blocks an enzyme which converts the cytosine nucleotide into the deoxy derivative. In addition, DNA synthesis is further inhibited because Fluorouracil blocks the incorporation of the thymidine nucleotide into the DNA strand. Fluorouracil is used for the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Fluorouracil injection is indicated in the palliative management of some types of cancer, including colon, esophageal, gastric, rectum, breast, biliary tract, stomach, head and neck, cervical, pancreas, renal cell, and carcinoid. — NCATS
Clinical trial activity
2,567 trials · 1,101 clinical orgs · 36 marketing orgs
Phase 1
483
Phase 2
2027
Phase 3
707
Phase 4
58
Earliest trial started Sep 1, 1977 (NCT00427570)
Timeline
1960s
- Apr 25, 1962
Earliest FDA Approval
- Apr 25, 1962
Spectrum Pharmaceuticals — NDA Secondary Org
1970s
- Jul 29, 1970
Bausch Health Companies — First NDA Organization
- Jul 29, 1970
Bausch Health Companies — NDA Secondary Org
- Jul 29, 1970
Bausch Health Companies — Marketing Organization
- Jul 29, 1970
Bausch Health Companies — NDA Organization
- Jul 29, 1970
EXTROVIS — Marketing Organization
- Jul 31, 1970
Elorac, Inc. — NDA Secondary Org
- Aug 6, 1971
Chartwell Pharmaceuticals — Marketing Organization
- Aug 6, 1971
Almirall — NDA Secondary Org
- Aug 6, 1971
Chartwell Pharmaceuticals — NDA Secondary Org
- Jan 1, 1977
Earliest Phase 3 Sponsor(trial)
- Jan 1, 1978
Earliest Phase 2 Sponsor(trial)
1980s
- Oct 13, 1982
Spectrum Pharmaceuticals — Marketing Organization
- Jan 18, 1983
Marchar — Marketing Organization
- Jan 1, 1988
Earliest Phase 1 Sponsor(trial)
- Jan 26, 1988
Bedford Pharmaceuticals — Marketing Organization
1990s
- Sep 30, 1998
Fresenius — Marketing Organization
2000s
- Jan 27, 2000
Teva — Marketing Organization
- Nov 5, 2003
Taro Pharmaceuticals — Marketing Organization
- Apr 26, 2007
Accord Research — Marketing Organization
- Apr 11, 2008
Mayne Pharma — Marketing Organization
- Apr 11, 2008
Dr. Reddy's Laboratories — Marketing Organization
- Aug 11, 2008
EBEWE Pharma — Marketing Organization
2010s
- Mar 5, 2010
Sun Pharmaceuticals — Marketing Organization
- May 2, 2011
Sandoz — Marketing Organization
- May 2, 2011
Novartis — Marketing Organization
- Jul 17, 2012
Eugia Pharma — Marketing Organization
- Jul 17, 2012
Mylan — Marketing Organization
- Sep 18, 2015
Hill Dermaceuticals, Inc. — NDA Secondary Org
- Feb 17, 2016
Sagent Pharmaceuticals, Inc. — Marketing Organization
- May 11, 2017
Nichi-Iko Pharmaceutical Co., Ltd. — Marketing Organization
- Oct 27, 2017
Gland Pharma Ltd — Marketing Organization
- Oct 27, 2017
Fosun — Marketing Organization
- Dec 11, 2019
Ingenus Pharmaceuticals — Marketing Organization
- Dec 11, 2019
Novast Labs — Marketing Organization
2020s
- Mar 3, 2023
Alembic — Marketing Organization
- Nov 2, 2023
Encube Ethicals Pvt. Ltd. — Marketing Organization
- Sep 24, 2024
KINDOS — Marketing Organization
- Feb 20, 2026
AVYXA HOLDINGS — Marketing Organization
Indications
Approved for
Studied for
- Abdominal Neoplasms · Phase 2
- Acute Kidney Injury · Phase 2
- Adenocarcinoma · Phase 3
- Adenoma, Islet Cell · Phase 2/Phase 3
- Anemia · Phase 1
- Antibody-Dependent Cell Cytotoxicity · Phase 2
- Antimetabolites · Phase 2
- Antineoplastic Agents · Phase 3
- Antineoplastic Combined Chemotherapy Protocols · Phase 2
- Anus Neoplasms · Phase 3
- Appendiceal Neoplasms · Phase 1
- Appendix · Phase 2
- Ascites · Phase 2
- Ascorbic Acid · Phase 3
- Basal Cell Carcinoma · Phase 4
- Basal Cell Nevus Syndrome · Phase 1/Phase 2
- Behavior Therapy · Phase 2
- Bevacizumab · Phase 1/Phase 2
- Bile Duct Neoplasms · Phase 2/Phase 3
- Biliary Tract Diseases · Phase 2
- Biliary Tract Neoplasms · Phase 3
- Biopsy · Phase 2
- Biopsy, Large-Core Needle · Phase 2
- Bone Marrow Diseases · Phase 3
- Bowen's Disease · Phase 4
- Breast Neoplasms · Phase 4
- Capecitabine · Phase 3
- Carcinoid Tumor · Phase 2
- Carcinoma · Phase 4
- Carcinoma, Adenoid Cystic · Phase 1
- Carcinoma, Hepatocellular · Phase 3
- Carcinoma, Islet Cell · Phase 2
- Carcinoma, Mucoepidermoid · Phase 1
- Carcinoma, Neuroendocrine · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Carcinoma, Ovarian Epithelial · Phase 1
- Carcinoma, Pancreatic Ductal · Phase 2
- Carcinoma, Renal Cell · Phase 2
- Carcinoma, Squamous Cell · Phase 4
- Carcinoma, Transitional Cell · Phase 3
- Carcinoma, Verrucous · Phase 3
- Cardiotoxicity · Phase 3
- Cervical Intraepithelial Neoplasia · Phase 1
- Cetuximab · Phase 3
- Chalazion · Phase 3
- Chemoradiotherapy · Phase 3
- Chemotherapy, Adjuvant · Phase 3
- Child · Phase 2
- Chitosan · Phase 1
- Cholangiocarcinoma · Phase 4
- Chondrosarcoma · Phase 1
- Choriocarcinoma · Phase 1
- Circulating Tumor DNA · Phase 2
- Cognition Disorders · Phase 3
- Colonic Diseases · Phase 2
- Colonic Neoplasms · Phase 4
- Colorectal Neoplasms · Phase 4
- Colorectal Neoplasms, Hereditary Nonpolyposis · Phase 3
- Corneal Diseases · Phase 4
- Cystitis · Phase 1
- Cytokine-Induced Killer Cells · Phase 4
- Dacryocystorhinostomy · Phase 1
- Dermatology · Phase 4
- Diabetes Mellitus, Type 2 · Phase 4
- Diarrhea · Phase 2
- Digestive System Neoplasms · Phase 3
- Disseminated Intravascular Coagulation · Phase 2
- DNA Repair-Deficiency Disorders · Phase 3
- Docetaxel · Phase 2/Phase 3
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Drugs, Investigational · Phase 3
- Drug Therapy · Phase 3
- Ectropion · Early Phase 1
- Endometrial Neoplasms · Phase 2
- Ependymoma · Phase 1
- Epidermal Growth Factor · Phase 2
- Epstein-Barr Virus Infections · Phase 2/Phase 3
- Esophageal Diseases · Phase 3
- Esophageal Neoplasms · Phase 4
- Esophageal Squamous Cell Carcinoma · Phase 3
- Esophagogastric Junction · Phase 3
- Exanthema · Phase 2
- Eyebrows · Phase 3
- Fallopian Tube Neoplasms · Phase 2
- Fever · Phase 3
- Fluorouracil · Phase 4
- Gallbladder Neoplasms · Phase 3
- Gastrectomy · Phase 2/Phase 3
- Gastric Bypass · Phase 2/Phase 3
- Gastrointestinal Diseases · Phase 1/Phase 2
- Gastrointestinal Neoplasms · Phase 3
- Gastrointestinal Stromal Tumors · Phase 1
- General Surgery · Phase 3
- Genes, erbB-2 · Phase 2
- Genes, ras · Phase 2
- Geriatrics · Phase 3
- Germinoma · Phase 1
- Glaucoma · Phase 4
- Glaucoma, Open-Angle · Phase 4
- Glioblastoma · Phase 1/Phase 2
- Glioma · Phase 1
- Graft vs Host Disease · Phase 2
- Granuloma · Phase 1
- Hamartoma · Phase 3
- Head and Neck Neoplasms · Phase 4
- Hematologic Diseases · Phase 3
- Hepatoblastoma · Phase 3
- HIV Infections · Phase 3
- Hodgkin Disease · Phase 1
- Hospital Costs · Phase 3
- Human papillomavirus 16 · Phase 2
- Hyperthermia · Phase 2
- Hypopharyngeal Neoplasms · Phase 3
- Immune Checkpoint Inhibitors · Phase 2
- Immunotherapy · Phase 3
- Inflammatory Breast Neoplasms · Phase 3
- Intestinal Diseases · Phase 2
- Intestinal Neoplasms · Phase 4
- Irinotecan · Phase 2/Phase 3
- Kartagener Syndrome · Phase 2
- Keloid · Phase 4
- Keratosis, Actinic · Phase 4
- Kidney · Phase 1/Phase 2
- Kidney Neoplasms · Phase 3
- Klatskin Tumor · Phase 2
- Lapatinib · Phase 3
- Laryngeal Neoplasms · Phase 3
- Length of Stay · Phase 3
- Leucogenenol · Phase 3
- Leukemia · Phase 1
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 1
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 1
- Leukemia, Myeloid, Acute · Phase 2
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative · Phase 1
- Leukemia, Myeloid, Chronic-Phase · Phase 1
- Leukemia, Myelomonocytic, Chronic · Phase 1
- Leukoplakia, Oral · Phase 1
- Liver Diseases · Phase 2
- Liver Neoplasms · Phase 4
- Liver Transplantation · Phase 3
- Lung Neoplasms · Phase 2/Phase 3
- Lymphoma · Phase 2
- Lymphoma, Non-Hodgkin · Phase 1
- Lymphoma, Primary Cutaneous Anaplastic Large Cell · Phase 1
- Melanoma · Phase 1
- Mesothelioma · Phase 2
- Microsatellite Instability · Phase 3
- Monitoring, Immunologic · Phase 1/Phase 2
- Mouth Neoplasms · Phase 3
- Mucositis · Early Phase 1
- Multiple Myeloma · Phase 1/Phase 2
- Mutation · Phase 3
- Myelodysplastic Syndromes · Phase 1
- Myeloproliferative Disorders · Phase 1
- Nasopharyngeal Carcinoma · Phase 3
- Nasopharyngeal Diseases · Phase 3
- Nasopharyngeal Neoplasms · Phase 3
- Nausea · Phase 2
- Neoadjuvant Therapy · Phase 4
- Neoplasm Metastasis · Phase 4
- Neoplasm Recurrence, Local · Phase 3
- Neoplasms, Basal Cell · Phase 4
- Neoplasms, Germ Cell and Embryonal · Phase 2
- Neoplasms, Second Primary · Phase 3
- Neoplasms, Squamous Cell · Phase 4
- Neoplastic Cells, Circulating · Phase 3
- Neoplastic Syndromes, Hereditary · Phase 2/Phase 3
- Nerve Sheath Neoplasms · Phase 3
- Neuroblastoma · Phase 1
- Neuroendocrine Tumors · Phase 4
- Neutropenia · Phase 3
- Nose Neoplasms · Phase 2
- Odontogenic Cysts · Phase 4
- Organoids · Phase 2
- Organ Transplantation · Phase 3
- Oropharyngeal Neoplasms · Phase 4
- Ovarian Neoplasms · Phase 2
- Oxaliplatin · Phase 2/Phase 3
- Pain · Phase 1/Phase 2
- Pancreatectomy · Phase 3
- Pancreatic Intraductal Neoplasms · Phase 3
- Pancreatic Neoplasms · Phase 4
- Papilloma, Inverted · Phase 1
- Papillomaviridae · Phase 2
- Papillomavirus Infections · Phase 3
- Paranasal Sinus Neoplasms · Phase 3
- Pathology · Phase 2/Phase 3
- Pediatrics · Phase 3
- Perioperative Period · Phase 2
- Peripheral Nervous System Diseases · Phase 2/Phase 3
- Peritoneal Neoplasms · Phase 3
- Pharmacokinetics · Phase 2
- Pharmacological and Toxicological Phenomena · Phase 2
- Pharyngeal Neoplasms · Phase 3
- Photosensitivity Disorders · Phase 4
- Postoperative Complications · Phase 4
- Precancerous Conditions · Phase 1
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 1
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Primary Myelofibrosis · Phase 1
- Progression-Free Survival · Phase 2
- Prostatic Neoplasms · Phase 1
- Prostatic Neoplasms, Castration-Resistant · Phase 2
- Proto-Oncogene Proteins B-raf · Phase 2
- Proto-Oncogene Proteins p21(ras) · Phase 1/Phase 2
- Prurigo · Phase 3
- Pterygium · Phase 4
- Quality of Life · Phase 3
- Radiation · Phase 3
- Radiation Oncology · Phase 2
- Radiotherapy · Phase 2/Phase 3
- ras Proteins · Phase 3
- Receptors, Tumor Necrosis Factor, Type I · Phase 2/Phase 3
- Rectal Neoplasms · Phase 4
- Recurrence · Phase 3
- Retinal Diseases · Phase 3
- Safety · Phase 2
- Salivary Gland Neoplasms · Phase 3
- Sarcoma · Phase 2
- Self Efficacy · Phase 2
- Seminoma · Phase 2
- Sepsis · Phase 3
- Skin Diseases · Phase 4
- Skin Neoplasms · Phase 4
- Small Cell Lung Carcinoma · Phase 2
- Squamous Cell Carcinoma of Head and Neck · Phase 4
- Squamous Intraepithelial Lesions · Phase 3
- Stem Cell Transplantation · Phase 2
- Stomach Neoplasms · Phase 4
- Survival · Phase 4
- Testicular Neoplasms · Phase 2
- Thymidylate Synthase · Phase 2
- Thyroid Neoplasms · Phase 2
- Tongue Neoplasms · Phase 3
- Trabeculectomy · Phase 4
- Triple Negative Breast Neoplasms · Phase 2
- Ureteral Neoplasms · Phase 2
- Urethral Neoplasms · Phase 2
- Urinary Bladder Neoplasms · Phase 3
- Uterine Cervical Dysplasia · Phase 3
- Uterine Cervical Neoplasms · Phase 3
- Uterine Neoplasms · Phase 2
- Vitiligo · Phase 4
- Vitreoretinopathy, Proliferative · Phase 3
- Warts · Phase 4
- Wound Healing · Phase 4
- Yang Deficiency · Phase 2
- Yin Deficiency · Phase 2
- Zollinger-Ellison Syndrome · Phase 2
Mechanism of action
- Thymidylate synthaseINHIBITOR
TYMS inhibitor
- RNAINHIBITOR
RNA inhibitor
- DNAINHIBITOR
DNA inhibitor
Approval history
- approvedPriority reviewApr 25, 1962
Chemistry & pharmacology
Loading structure…
SMILES
FC1=CNC(=O)NC1=O- Mol. weight
- 130.0772 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral, Topical
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
Yes
Sources
- WikipediaFluorouracil ↗
- NCATSU3P01618RT ↗
- ChEMBLCHEMBL185 ↗
Also known as
- 5-flourouracil
- 5-fluoracil
- 5-fluoracil
- 5-fluoropyrimidine-2,4-dione
- 5-fluoropyrimidine-2,4-dione
- 5 fluorouracil
- 5 fluorouracil
- 5-fluorouracil
- 5-fluorouracil
- 5-fluorouracil
- 5-fluorouracil
- 5-fluorouracil
- 5-fluorouracil
- 5-fluorouracil
- 5-fluracil
- 5-fluracil
- 5-fluracil
- 5-fu
- 5-fu
- 5-fu
- 5-fu
- 5-fu
- 5.f.u.
- accusite
- accusite
- actikerall
- adrucil
- adrucil
- adrucil
- adrucil
- carac
- carac
- carac
- efudex
- efudex
- efudex
- efudex
- efudix
- efudix
- fluoroblastin
- fluoroplex
- fluoroplex
- fluoroplex
- fluorouracil
- fluorouracil
- fluorouracil
- fluorouracil
- fluorouracil
- fluorouracil
- fluorouracil
- fluorouracil
- fluorouracil
- fluoro uracil
- fluoro uracil
- fluoro uracil
- fluorouracil.
- fluorouracil.
- fluorouracilo
- fluorouracilo
- fluoro-uracil roche
- fluorouracilum
- fluorouracilum
- fluoruracil
- fluoruracil
- fluouracil
- fluouracil
- fluouracil
- fluracil
- fluracil
- fluracil
- folfiri
- folfiri
- folfirinox
- folfox
- folfox
- folfox-4
- folfox-4
- fu
- fu
- ro-29757
- ro-29757
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07271355 | Phase 3 | Jul 1, 2026 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT07041749 | N/A | Jun 1, 2026 | Assiut University |
| NCT07283705 | Phase 2 | May 18, 2026 | Bristol-Myers Squibb, University of Texas at Houston |
| NCT07221149 | Phase 2/Phase 3 (Phase 3) | Mar 9, 2026 | Biontech, Bristol-Myers Squibb |
| NCT07221357 | Phase 2/Phase 3 (Phase 3) | Mar 4, 2026 | Biontech, Bristol-Myers Squibb |
| NCT07290985 | Phase 2 | Mar 1, 2026 | American Association for Cancer Research, Jazz Pharmaceuticals |
| NCT06978062 | Phase 1 | Feb 20, 2026 | European Organisation for Research and Treatment of Cancer, Johannes Gutenburg University, University of Mannheim, University of Oxford |
| NCT07284849 | Phase 3 | Feb 16, 2026 | Incyte |
| NCT07283848 | Phase 2 | Feb 1, 2026 | Arcus Biosciences, Inc., Gateway for Cancer Research, Harvard University |
| NCT06998940 | Phase 3 | Jan 6, 2026 | National Cancer Institute (NCI), SWOG Cancer Research Network |
| NCT07004413 | Phase 3 | Jan 1, 2026 | Humboldt University |
| NCT07298772 | Phase 1/Phase 2 (Phase 2) | Dec 31, 2025 | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| NCT07229846 | Phase 2 | Dec 31, 2025 | Harbin Medical University |
| NCT07238283 | Phase 3 | Dec 31, 2025 | Hengrui Therapeutics, Inc. |
| NCT07255404 | Phase 2 | Dec 31, 2025 | Biontech, Bristol-Myers Squibb |
| NCT07150403 | Phase 2 | Dec 31, 2025 | Federation Francophone de Cancerologie Digestive |
| NCT06783491 | Phase 3 | Dec 31, 2025 | Spanish Association of Surgeons (AEC), Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD), Universidad de Cordoba |
| NCT07251062 | Phase 2/Phase 3 (Phase 3) | Dec 30, 2025 | Shijiazhuang Pharma Group (CSPC) |
| NCT06967987 | Phase 2 | Dec 30, 2025 | Institut de Cancerologie de l'Ouest Paul Papin |
| NCT07277842 | Phase 3 | Dec 29, 2025 | Sun Yat-Sen University |
Showing 20 of 2,567 trials
Page 1 / 129
Organizations
Research & Development (1,101)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 354 | 125 | 5 | 1977 |
| Sun Yat-Sen University | Academic/Hospital | 133 | 129 | 3 | 1998 |
| Fudan University | Academic/Hospital | 94 | 77 | 5 | 2006 |
| Sanofi | For profit | 83 | 33 | 4 | 1997 |
| Roche | For profit | 71 | 41 | 4 | 1998 |
| Harvard University | Academic/Hospital | 62 | 40 | 3 | 1994 |
| University of Texas at Houston | Academic/Hospital | 57 | 42 | 4 | 1992 |
| Merck | For profit | 51 | 26 | 4 | 2005 |
| UNICANCER | Academic/Hospital | 47 | 41 | 2 | 1994 |
| Amgen | For profit | 46 | 19 | 4 | 2002 |
| Bristol-Myers Squibb | For profit | 43 | 14 | 3 | 1999 |
| Genentech | For profit | 43 | 17 | 4 | 2001 |
| Cornell University | Academic/Hospital | 42 | 29 | 4 | 1995 |
| Jiao Tong University | Academic/Hospital | 42 | 31 | 5 | 1997 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 41 | 26 | 4 | 2002 |
| Federation Francophone de Cancerologie Digestive | Academic/Hospital | 41 | 32 | 2 | 1993 |
| Zhejiang University | Academic/Hospital | 41 | 29 | 5 | 2006 |
| European Organisation for Research and Treatment of Cancer | Academic/Hospital | 40 | 35 | 4 | 1993 |
| Pfizer | For profit | 35 | 17 | 4 | 1999 |
| Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) | Academic/Hospital | 33 | 27 | 3 | 1998 |
1,101 organizations
Page 1 / 56
Marketing (49)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AVYXA HOLDINGS | For profit | MKTG | Feb 20, 2026 |
| Abic | For profit | MKTG | — |
| Abraxis | For profit | MKTG | — |
| Accord Research | For profit | MKTG | Apr 26, 2007 |
| Alembic | For profit | MKTG | Mar 3, 2023 |
| Alembic | For profit | SYN | Oct 18, 2023 |
| Almirall | For profit | NDA2 | Aug 6, 1971 |
| Athenex, Inc. | For profit | MKTG | — |
| Bausch Health Companies | For profit | NDA2 | Jul 29, 1970 |
| Bausch Health Companies | For profit | SYN | Oct 27, 2000 |
| Bausch Health Companies | For profit | MKTG | Jul 29, 1970 |
| Bausch Health Companies | For profit | NDA | Jul 29, 1970 |
| Bedford Pharmaceuticals | For profit | MKTG | Jan 26, 1988 |
| Chartwell Pharmaceuticals | For profit | MKTG | Aug 6, 1971 |
| Chartwell Pharmaceuticals | For profit | NDA2 | Aug 6, 1971 |
| Dr. Reddy's Laboratories | For profit | MKTG | Apr 11, 2008 |
| EBEWE Pharma | For profit | MKTG | Aug 11, 2008 |
| EXTROVIS | For profit | MKTG | Jul 29, 1970 |
| Elorac, Inc. | For profit | NDA2 | Jul 31, 1970 |
| Encube Ethicals Pvt. Ltd. | For profit | MKTG | Nov 2, 2023 |
| Eugia Pharma | For profit | MKTG | Jul 17, 2012 |
| Fosun | For profit | MKTG | Oct 27, 2017 |
| Fresenius | For profit | MKTG | Sep 30, 1998 |
| Gland Pharma Ltd | For profit | MKTG | Oct 27, 2017 |
| Gland Pharma Ltd | For profit | SYN | Oct 27, 2017 |
| Hill Dermaceuticals, Inc. | For profit | NDA2 | Sep 18, 2015 |
| Ingenus Pharmaceuticals | For profit | MKTG | Dec 11, 2019 |
| KINDOS | For profit | MKTG | Sep 24, 2024 |
| Marchar | For profit | MKTG | Jan 18, 1983 |
| Mayne Pharma | For profit | MKTG | Apr 11, 2008 |
| Mylan | For profit | MKTG | Jul 17, 2012 |
| Mylan | For profit | SYN | Apr 20, 2015 |
| Mylan | For profit | SYN | Apr 20, 2015 |
| Nichi-Iko Pharmaceutical Co., Ltd. | For profit | MKTG | May 11, 2017 |
| Novartis | For profit | MKTG | May 2, 2011 |
| Novast Labs | For profit | MKTG | Dec 11, 2019 |
| Pharmacia & Upjohn | For profit | NDA2 | — |
| Pharmacia & Upjohn | For profit | MKTG | — |
| Sagent Pharmaceuticals, Inc. | For profit | MKTG | Feb 17, 2016 |
| Sagent Pharmaceuticals, Inc. | For profit | SYN | Feb 17, 2016 |
| Sandoz | For profit | MKTG | May 2, 2011 |
| Smith & Nephew | For profit | MKTG | — |
| Spectrum Pharmaceuticals | For profit | NDA2 | Apr 25, 1962 |
| Spectrum Pharmaceuticals | For profit | MKTG | Oct 13, 1982 |
| Sun Pharmaceuticals | For profit | MKTG | Mar 5, 2010 |
| Taro Pharmaceuticals | For profit | SYN | Mar 5, 2010 |
| Taro Pharmaceuticals | For profit | MKTG | Nov 5, 2003 |
| Teva | For profit | SYN | Aug 28, 1991 |
| Teva | For profit | MKTG | Jan 27, 2000 |