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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 219196

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NDA 219196 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 219196

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

Pharmacology for NDA: 219196

Suppliers and Packaging for NDA: 219196

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CALCITONIN-SALMON	calcitonin salmon	INJECTABLE;INJECTION	219196	ANDA	Sagent Pharmaceuticals	25021-473	25021-473-02	1 VIAL in 1 CARTON (25021-473-02) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	200 IU/ML
Approval Date:	Jul 9, 2025	TE:	AP	RLD:	No

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