Active ingredient
Fulvestrant
26 finished FDA listings contain Fulvestrant as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- FULVESTRANT
- Dosage forms
- Injection, Injection, Solution
- Routes
- Intramuscular, Intravenous
- Manufacturers / labelers
- 22
- Strengths listed
- 250 mg/5ml · 50 mg/ml
- Brand names in FDA listings
- Cligavyx, Faslodex
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 282357
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021344 | ASTRAZENECA | 2002-04-25 | 1 |
| ANDA 210044 | AMNEAL | 2019-03-04 | 3 |
| ANDA 205935 | SANDOZ | 2019-05-14 | 2 |
| NDA 210326 | FRESENIUS KABI USA | 2019-05-20 | 1 |
| NDA 210063 | AVYXA HOLDINGS | 2019-08-19 | 1 |
| ANDA 207754 | GLENMARK PHARMS | 2019-08-22 | 1 |
| ANDA 209714 | HBT LABS INC | 2019-11-21 | 1 |
| ANDA 211422 | CHIA TAI TIANQING | 2020-02-07 | 5 |
| ANDA 209246 | DR REDDYS | 2020-08-07 | 1 |
| ANDA 211689 | ACCORD HLTHCARE | 2020-11-17 | 2 |
| ANDA 215234 | ZYDUS PHARMS | 2021-07-29 | 2 |
| ANDA 213553 | XIROMED | 2021-08-13 | 2 |
| ANDA 214682 | JIANGSU HANSOH PHARM | 2022-02-10 | 1 |
| ANDA 215077 | ALEMBIC | 2022-12-22 | 2 |
| ANDA 215169 | EUGIA PHARMA | 2023-06-30 | 1 |
Official labeling on DailyMed
- CLIGAVYX (FULVESTRANT) INJECTION [AVYXA PHARMA, LLC] · version 6 · 2026-07-01
- FULVESTRANT INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] · version 1 · 2026-04-15
- FULVESTRANT INJECTION [GLENMARK PHARMACEUTICALS INC., USA] · version 8 · 2026-03-02
- FASLODEX (FULVESTRANT) INJECTION [ASTRAZENECA PHARMACEUTICALS LP] · version 43 · 2026-02-16
- FULVESTRANT INJECTION [HIKMA PHARMACEUTICALS USA INC.] · version 4 · 2026-02-12
- FULVESTRANT INJECTION [CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD.] · version 6 · 2025-12-29
- FULVESTRANT INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC] · version 1 · 2025-12-19
- FULVESTRANT INJECTION [ALEMBIC PHARMACEUTICALS INC.] · version 10 · 2025-08-21
- FULVESTRANT INJECTION [BLUEPOINT LABORATORIES.] · version 3 · 2025-07-28
- FULVESTRANT INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC] · version 16 · 2025-07-14
- FULVESTRANT INJECTION [EUGIA US LLC] · version 3 · 2025-07-07
- FULVESTRANT INJECTION, SOLUTION [BLUEPOINT LABORATORIES] · version 3 · 2025-06-26
Showing the 12 most recent of 25 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.