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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021406

FORTICAL (CALCITONIN SALMON RECOMBINANT)
200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CALCITONIN SALMON RECOMBINANT
Proprietary Name: FORTICAL
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021406
Product Number: 001
Approval Date: Aug 12, 2005
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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