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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 212416

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NDA 212416 describes CALCITONIN-SALMON, which is a drug marketed by Amneal, Cipla, Custopharm Inc, Dr Reddys, Fresenius Kabi Usa, Igi Labs Inc, Ph Health, Sagent, and Apotex Inc, and is included in ten NDAs. It is available from nine suppliers. Additional details are available on the CALCITONIN-SALMON profile page.

The generic ingredient in CALCITONIN-SALMON is calcitonin salmon. There are fourteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the calcitonin salmon profile page.

Summary for 212416

Tradename:	CALCITONIN-SALMON
Applicant:	Custopharm Inc
Ingredient:	calcitonin salmon
Patents:	0

Pharmacology for NDA: 212416

Suppliers and Packaging for NDA: 212416

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CALCITONIN-SALMON	calcitonin salmon	INJECTABLE;INJECTION	212416	ANDA	Hikma Pharmaceuticals USA Inc.	24201-400	24201-400-02	1 VIAL, MULTI-DOSE in 1 CARTON (24201-400-02) / 2 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	200 IU/ML
Approval Date:	May 14, 2021	TE:	AP	RLD:	No

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