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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 212675

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NDA 212675 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 eight 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. Nine suppliers are listed for this compound. Additional details are available on the calcitonin salmon profile page.

Summary for 212675

Tradename:	CALCITONIN-SALMON
Applicant:	Fresenius Kabi Usa
Ingredient:	calcitonin salmon
Patents:	0

Pharmacology for NDA: 212675

Suppliers and Packaging for NDA: 212675

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CALCITONIN-SALMON	calcitonin salmon	INJECTABLE;INJECTION	212675	ANDA	Fresenius Kabi USA, LLC	63323-865	63323-865-02	1 VIAL, MULTI-DOSE in 1 CARTON (63323-865-02) / 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:	Dec 5, 2024	TE:	AP	RLD:	No

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