Active ingredient
Salmon Calcitonin
14 finished FDA listings contain Salmon Calcitonin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CALCITONIN SALMON, CALCITONIN SALMON ACETATE
- Dosage forms
- Injection, Solution, Spray, Metered
- Routes
- Intramuscular, Nasal, Subcutaneous
- Manufacturers / labelers
- 11
- Strengths listed
- 200 [iu]/.09ml · 200 [iu]/1 · 200 [iu]/ml · 200 [usp'u]/ml · 400 [usp'u]/2ml
- Brand names in FDA listings
- Miacalcin
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 36118
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 017808 | MYLAN IRELAND LTD | 1986-07-03 | 3 |
| ANDA 076396 | APOTEX INC | 2008-11-17 | 1 |
| ANDA 076979 | PH HEALTH | 2009-06-08 | 1 |
| ANDA 212416 | CUSTOPHARM INC | 2021-05-14 | 1 |
| ANDA 209358 | PH HEALTH | 2021-11-10 | 1 |
| ANDA 215715 | DR REDDYS | 2024-04-11 | 1 |
| ANDA 213766 | CIPLA | 2024-09-20 | 1 |
| ANDA 212675 | FRESENIUS KABI USA | 2024-12-05 | 1 |
| ANDA 219196 | SAGENT | 2025-07-09 | 1 |
| ANDA 216294 | AMNEAL | 2025-09-26 | 1 |
| ANDA 215864 | ZYDUS PHARMS | 2026-03-04 | 2 |
Official labeling on DailyMed
- CALCITONIN SALMON SPRAY, METERED [APOTEX CORP.] · version 14 · 2026-09-11
- CALCITONIN SALMON INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 3 · 2026-07-30
- CALCITONIN SALMON SPRAY, METERED [PAR HEALTH USA, LLC] · version 22 · 2026-07-06
- MIACALCIN (CALCITONIN SALMON) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 5 · 2026-06-19
- MIACALCIN (CALCITONIN SALMON) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 5 · 2026-06-19
- MIACALCIN (CALCITONIN SALMON) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 9 · 2026-06-19
- CALCITONIN SALMON INJECTION, SOLUTION [DR. REDDY'S LABORATORIES, INC.] · version 4 · 2026-06-10
- CALCITONIN SALMON INJECTION, SOLUTION [PAR HEALTH USA, LLC] · version 8 · 2026-04-27
- CALCITONIN SALMON INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS USA INC.] · version 1 · 2026-04-10
- CALCITONIN SALMON INJECTION, SOLUTION [ZYDUS LIFESCIENCES LIMITED] · version 1 · 2026-04-10
- CALCITONIN SALMON INJECTION, SOLUTION [CIPLA USA INC.] · version 7 · 2025-11-25
- CALCITONIN SALMON INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC] · version 3 · 2025-10-02
Showing the 12 most recent of 14 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.