Active ingredient
Leuprolide
12 finished FDA listings contain Leuprolide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LEUPROLIDE, LEUPROLIDE ACETATE, LEUPROLIDE MESYLATE
- Dosage forms
- Injection, Injection, Emulsion, Injection, Suspension, Extended Release
- Routes
- Subcutaneous
- Manufacturers / labelers
- 4
- Strengths listed
- 1 mg/.2ml · 22.5 mg/.375ml · 30 mg/.5ml · 42 mg/.37g · 45 mg/.375ml · 7.5 mg/.25ml
- Brand names in FDA listings
- Camcevi, Eligard, Fensolvi, Vabrinty
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 42375
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 021343 | TOLMAR | 2002-01-23 | 2 |
| NDA 021379 | TOLMAR | 2002-07-24 | 2 |
| NDA 021488 | TOLMAR | 2003-02-13 | 2 |
| NDA 021731 | TOLMAR | 2004-12-14 | 2 |
| NDA 213150 | TOLMAR | 2020-05-01 | 1 |
| NDA 211488 | ACCORD | 2021-05-25 | 2 |
| ANDA 217437 | PH HEALTH | 2025-06-09 | 1 |
Official labeling on DailyMed
- LEUPROLIDE ACETATE INJECTION [ENDO USA, INC.] · version 7 · 2026-06-30
- VABRINTY (LEUPROLIDE ACETATE) INJECTION, SUSPENSION, EXTENDED RELEASE [URONOVA PHARMACEUTICALS, INC.] · version 10 · 2026-06-26
- ELIGARD (LEUPROLIDE ACETATE) INJECTION, SUSPENSION, EXTENDED RELEASE [TOLMAR INC.] · version 19 · 2026-05-11
- CAMCEVI (LEUPROLIDE) INJECTION, EMULSION [ACCORD BIOPHARMA, INC.] · version 9 · 2026-02-19
- FENSOLVI (LEUPROLIDE ACETATE) INJECTION, SUSPENSION, EXTENDED RELEASE [TOLMAR INC.] · version 12 · 2025-09-29
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.