Data / Drug companies / Fulvestrant
Fulvestrant: 21 companies and 25 products in the FDA NDC directory
Fulvestrant is listed in the FDA National Drug Code Directory by 21 companies, with 25 products in commercial distribution. 22 of the products (88.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, solution; injection, and the newest product started marketing on July 1, 2026.
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- Companies listing it
- 21
- Products
- 25
- Generic (ANDA) products
- 22 (88.0%)
- Application numbers
- 15
- Routes
- Intramuscular, Intravenous
- Brand names
- Faslodex, Cligavyx
- openFDA record search
- api.fda.gov
Companies that list fulvestrant
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Amneal Pharmaceuticals LLC | 2 | injection, solution | Generic drugs (ANDA) | June 3, 2025 |
| BluePoint Laboratories | 2 | injection; injection, solution | Generic drugs (ANDA) | January 17, 2025 |
| Sagent Pharmaceuticals | 2 | injection, solution | Generic drugs (ANDA) | April 15, 2026 |
| Sandoz Inc | 2 | injection | Generic drugs (ANDA) | November 1, 2023 |
| Accord Healthcare Inc. | 1 | injection | Generic drugs (ANDA) | January 21, 2021 |
| Alembic Pharmaceuticals Inc. | 1 | injection | Generic drugs (ANDA) | December 22, 2022 |
| AstraZeneca Pharmaceuticals LP | 1 | injection | New drug applications (NDA) | November 1, 2010 |
| Athenex Pharmaceutical Division, LLC. | 1 | injection, solution | Generic drugs (ANDA) | February 18, 2020 |
| Avenacy, LLC | 1 | injection, solution | Generic drugs (ANDA) | February 28, 2024 |
| Avyxa Pharma, LLC | 1 | injection | New drug applications (NDA) | July 1, 2026 |
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 1 | injection | Generic drugs (ANDA) | April 1, 2021 |
| Dr. Reddy's Laboratories Inc. | 1 | injection, solution | Generic drugs (ANDA) | December 31, 2023 |
| Eugia US LLC | 1 | injection | Generic drugs (ANDA) | June 30, 2023 |
| Fresenius Kabi USA, LLC | 1 | injection, solution | New drug applications (NDA) | May 20, 2019 |
| Glenmark Pharmaceuticals Inc., USA | 1 | injection | Generic drugs (ANDA) | August 22, 2019 |
| Hikma Pharmaceuticals USA Inc. | 1 | injection | Generic drugs (ANDA) | February 10, 2022 |
| Meitheal Pharmaceuticals Inc. | 1 | injection | Generic drugs (ANDA) | November 21, 2019 |
| NorthStar Rx LLC | 1 | injection, solution | Generic drugs (ANDA) | August 23, 2021 |
| Xiromed, LLC | 1 | injection, solution | Generic drugs (ANDA) | August 19, 2021 |
| Zydus Lifesciences Limited | 1 | injection, solution | Generic drugs (ANDA) | December 14, 2021 |
| Zydus Pharmaceuticals USA Inc. | 1 | injection, solution | Generic drugs (ANDA) | December 14, 2021 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, solution | 13 | 52% |
| Injection | 12 | 48% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 22 | 88% |
| New drug applications (NDA) | 3 | 12% |
Pharmacologic classes
| Class | Products |
|---|---|
| Estrogen Receptor Antagonist | 25 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.