Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021574

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FORTAMET (METFORMIN HYDROCHLORIDE)
1GM
Marketing Status: Prescription

Active Ingredient: METFORMIN HYDROCHLORIDE
Proprietary Name: FORTAMET
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1GM
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB2
Application Number: N021574
Product Number: 002
Approval Date: Apr 27, 2004
Applicant Holder Full Name: ANDRX LABS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

FORTAMET (METFORMIN HYDROCHLORIDE)
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: METFORMIN HYDROCHLORIDE
Proprietary Name: FORTAMET
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021574
Product Number: 001
Approval Date: Apr 27, 2004
Applicant Holder Full Name: ANDRX LABS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information