Active ingredient
Milnacipran
25 finished FDA listings contain Milnacipran as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MILNACIPRAN HYDROCHLORIDE
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 7
- Strengths listed
- 100 mg/1 · 12.5 mg/1 · 25 mg/1 · 50 mg/1
- Brand names in FDA listings
- Savella
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 588250
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 022256 | ABBVIE | 2009-01-14 | 9 |
| ANDA 205071 | BRECKENRIDGE | 2016-01-27 | 4 |
| ANDA 205081 | AMNEAL PHARMS | 2016-04-22 | 4 |
| ANDA 205147 | HETERO LABS LTD V | 2024-10-03 | 4 |
| ANDA 210944 | MACLEODS PHARMS | 2026-09-15 | 4 |
Official labeling on DailyMed
- SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED SAVELLA (MILNACIPRAN HYDROCHLORIDE) KIT [ALLERGAN, INC.] · version 41 · 2026-08-27
- MILNACIPRAN HYDROCHLORIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] · version 4 · 2026-07-27
- MILNACIPRAN HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] · version 4 · 2026-03-26
- MILNACIPRAN HYDROCHLORIDE (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED MILNACIPRAN HYDROCHLORIDE KIT [CAMBER PHARMACEUTICALS, INC.] · version 1 · 2026-03-20
- SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] · version 11 · 2026-01-28
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.