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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216294

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NDA 216294 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 216294

Tradename:	CALCITONIN-SALMON
Applicant:	Amneal
Ingredient:	calcitonin salmon
Patents:	0

Pharmacology for NDA: 216294

Suppliers and Packaging for NDA: 216294

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CALCITONIN-SALMON	calcitonin salmon	INJECTABLE;INJECTION	216294	ANDA	Amneal Pharmaceuticals LLC	70121-1650	70121-1650-2	1 VIAL, MULTI-DOSE in 1 CARTON (70121-1650-2) / 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:	Sep 26, 2025	TE:	AP	RLD:	No

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