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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022386

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PRANDIMET (METFORMIN HYDROCHLORIDE; REPAGLINIDE)
500MG;1MG
Marketing Status: Discontinued
Active Ingredient: METFORMIN HYDROCHLORIDE; REPAGLINIDE
Proprietary Name: PRANDIMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG;1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022386
Product Number: 001
Approval Date: Jun 23, 2008
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
PRANDIMET (METFORMIN HYDROCHLORIDE; REPAGLINIDE)
500MG;2MG
Marketing Status: Discontinued
Active Ingredient: METFORMIN HYDROCHLORIDE; REPAGLINIDE
Proprietary Name: PRANDIMET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG;2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022386
Product Number: 002
Approval Date: Jun 23, 2008
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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