Orange Book product · Brand (NDA)
MIACALCIN
CALCITONIN SALMON
At a glance
Jul 03, 1986
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 03, 1986
40 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
CALCITONIN SALMON
Strength
100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 017808
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1995MIACALCINBrand (NDA)
NDA 020313 · PHARMOBEDIENT
- —CALCIMARBrand (NDA)
NDA 017769 · SANOFI AVENTIS US
- —CALCIMARBrand (NDA)
NDA 017497 · SANOFI AVENTIS US
- 2026CALCITONIN-SALMONGeneric (ANDA)
ANDA 215864 · ZYDUS PHARMS
- 2025CALCITONIN-SALMONGeneric (ANDA)
ANDA 216294 · AMNEAL
- 2025CALCITONIN-SALMONGeneric (ANDA)
ANDA 219196 · SAGENT
- 2024CALCITONIN-SALMONGeneric (ANDA)
ANDA 212675 · FRESENIUS KABI USA
- 2024CALCITONIN-SALMONGeneric (ANDA)
ANDA 213766 · CIPLA
- 2024CALCITONIN-SALMONGeneric (ANDA)
ANDA 215715 · DR REDDYS
- 2021CALCITONIN-SALMONGeneric (ANDA)
ANDA 209358 · PH HEALTH
- 2021CALCITONIN-SALMONGeneric (ANDA)
ANDA 212416 · CUSTOPHARM INC
- 2009CALCITONIN-SALMONGeneric (ANDA)
ANDA 076979 · PH HEALTH
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.
