Active ingredient
Ganirelix
10 finished FDA listings contain Ganirelix as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- GANIRELIX ACETATE
- Dosage forms
- Injection, Injection, Solution
- Routes
- Subcutaneous
- Manufacturers / labelers
- 10
- Strengths listed
- 250 ug/.5ml
- Brand names in FDA listings
- Fyremadel
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 35825
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 021057 | ORGANON USA ORGANON | 1999-07-29 | 1 |
| ANDA 204246 | SUN PHARM | 2018-11-30 | 1 |
| ANDA 212613 | AMPHASTAR PHARMS INC | 2022-04-07 | 1 |
| ANDA 214996 | MEITHEAL | 2022-06-06 | 1 |
| ANDA 215658 | GLAND | 2023-02-28 | 3 |
| ANDA 216075 | LUPIN | 2023-11-16 | 1 |
| ANDA 218855 | QILU | 2025-04-23 | 2 |
Official labeling on DailyMed
- GANIRELIX ACETATE INJECTION, SOLUTION [MULLAN PHARMACEUTICAL INC.] · version 2 · 2026-05-13
- GANIRELIX ACETATE INJECTION [XIROMED LLC] · version 2 · 2026-03-20
- GANIRELIX ACETATE INJECTION, SOLUTION [ORGANON LLC] · version 8 · 2025-11-17
- GANIRELIX ACETATE INJECTION, SOLUTION [LUPIN PHARMACEUTICALS, INC.] · version 8 · 2025-09-25
- GANIRELIX ACETATE INJECTION, SOLUTION [QILU PHARMACEUTICAL CO., LTD.] · version 2 · 2025-07-16
- GANIRELIX ACETATE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] · version 7 · 2025-04-17
- FYREMADEL (GANIRELIX ACETATE) INJECTION, SOLUTION [FERRING PHARMACEUTICALS INC.] · version 4 · 2025-01-09
- GANIRELIX ACETATE INJECTION [FRESENIUS KABI USA, LLC] · version 2 · 2024-05-30
- GANIRELIX ACETATE INJECTION, SOLUTION [GLAND PHARMA LIMITED] · version 3 · 2023-11-30
- GANIRELIX ACETATE INJECTION [AMPHASTAR PHARMACEUTICALS, INC.] · version 1 · 2022-06-20
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.