Last Updated: September 24, 2026

Details for New Drug Application (NDA): 020313

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NDA 020313 describes MIACALCIN, which is a drug marketed by Mylan Ireland Ltd and Saptalis Pharms 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 is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the calcitonin salmon profile page.

Summary for 020313

Tradename:	MIACALCIN
Applicant:	Saptalis Pharms
Ingredient:	calcitonin salmon
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SPRAY, METERED;NASAL			Strength	200 IU/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 17, 1995	TE:		RLD:	Yes

Expired US Patents for NDA 020313

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Saptalis Pharms	MIACALCIN	calcitonin salmon	SPRAY, METERED;NASAL	020313-002	Aug 17, 1995	5,733,569	⤷ Start Trial
Saptalis Pharms	MIACALCIN	calcitonin salmon	SPRAY, METERED;NASAL	020313-002	Aug 17, 1995	5,759,565	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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