FDA Orange Book · active-ingredient family
Calcitonin salmon
Calcitonin salmon is approved as 4 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MIACALCIN · NDA 020313
4
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, spray, metered
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MIACALCINRLD | PHARMOBEDIENT | NDA 020313 | — | Aug 17, 1995 | |
| MIACALCINRLD×2 | MYLAN IRELAND LTD | NDA 017808 | — | Jul 03, 1986 | |
| CALCIMARRLD | SANOFI AVENTIS US | NDA 017769 | — | Approved Prior to Jan 1, 1982 | |
| CALCIMAR | SANOFI AVENTIS US | NDA 017497 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CALCITONIN-SALMON | ZYDUS PHARMS | ANDA 215864 | AP | Mar 04, 2026 | |
| CALCITONIN-SALMON | AMNEAL | ANDA 216294 | AP | Sep 26, 2025 | |
| CALCITONIN-SALMON | SAGENT | ANDA 219196 | AP | Jul 09, 2025 | |
| CALCITONIN-SALMON | FRESENIUS KABI USA | ANDA 212675 | AP | Dec 05, 2024 | |
| CALCITONIN-SALMON | CIPLA | ANDA 213766 | AP | Sep 20, 2024 | |
| CALCITONIN-SALMON | DR REDDYS | ANDA 215715 | AP | Apr 11, 2024 | |
| CALCITONIN-SALMON | PH HEALTH | ANDA 209358 | AP | Nov 10, 2021 | |
| CALCITONIN-SALMON | CUSTOPHARM INC | ANDA 212416 | AP | May 14, 2021 | |
| CALCITONIN-SALMON | PH HEALTH | ANDA 076979 | AB | Jun 08, 2009 | |
| CALCITONIN-SALMON | APOTEX INC | ANDA 076396 | AB | Nov 17, 2008 | |
| CALCITONIN-SALMON | IGI LABS INC | ANDA 073690 | — | Apr 14, 1995 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Calcitonin salmon — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
