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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 215715

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NDA 215715 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 215715

Tradename:	CALCITONIN-SALMON
Applicant:	Dr Reddys
Ingredient:	calcitonin salmon
Patents:	0

Pharmacology for NDA: 215715

Suppliers and Packaging for NDA: 215715

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CALCITONIN-SALMON	calcitonin salmon	INJECTABLE;INJECTION	215715	ANDA	Dr. Reddy's Laboratories, Inc.	43598-051	43598-051-11	1 VIAL, MULTI-DOSE in 1 CARTON (43598-051-11) / 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:	Apr 11, 2024	TE:	AP	RLD:	No

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