Details for New Drug Application (NDA): 017808

NDA 017808 describes MIACALCIN, which is a drug marketed by Mylan Ireland Ltd and Norvium Bioscience and is included in two NDAs. It is available from one supplier. Additional details are available on the MIACALCIN profile page.

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

Summary for 017808

Tradename:	MIACALCIN
Applicant:	Mylan Ireland Ltd
Ingredient:	calcitonin salmon
Patents:	0

Pharmacology for NDA: 017808

Suppliers and Packaging for NDA: 017808

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MIACALCIN	calcitonin salmon	INJECTABLE;INJECTION	017808	NDA	Mylan Institutional LLC	67457-675	67457-675-02	1 VIAL, MULTI-DOSE in 1 CARTON (67457-675-02) / 2 mL in 1 VIAL, MULTI-DOSE
MIACALCIN	calcitonin salmon	INJECTABLE;INJECTION	017808	NDA	Mylan Institutional LLC	72078-038	72078-038-02	1 VIAL, MULTI-DOSE in 1 CARTON (72078-038-02) / 2 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Jul 3, 1986	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	200 IU/ML
Approval Date:	Mar 29, 1991	TE:	AP	RLD:	Yes

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