Details for New Drug Application (NDA): 021406

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NDA 021406 describes FORTICAL, which is a drug marketed by Upsher Smith Labs and is included in one NDA. Additional details are available on the FORTICAL profile page.

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

Summary for 021406

Tradename:	FORTICAL
Applicant:	Upsher Smith Labs
Ingredient:	calcitonin salmon recombinant
Patents:	0

Profile for product number 001

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SPRAY, METERED;NASAL			Strength	200 IU/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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 12, 2005	TE:		RLD:	No

Expired US Patents for NDA 021406

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upsher Smith Labs	FORTICAL	calcitonin salmon recombinant	SPRAY, METERED;NASAL	021406-001	Aug 12, 2005	6,440,392	⤷ Subscribe
Upsher Smith Labs	FORTICAL	calcitonin salmon recombinant	SPRAY, METERED;NASAL	021406-001	Aug 12, 2005	RE43580	⤷ Subscribe
Upsher Smith Labs	FORTICAL	calcitonin salmon recombinant	SPRAY, METERED;NASAL	021406-001	Aug 12, 2005	RE40812	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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