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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021748

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GLUMETZA (METFORMIN HYDROCHLORIDE)
500MG
Marketing Status: Prescription
Active Ingredient: METFORMIN HYDROCHLORIDE
Proprietary Name: GLUMETZA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB3
Application Number: N021748
Product Number: 001
Approval Date: Jun 3, 2005
Applicant Holder Full Name: SANTARUS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
GLUMETZA (METFORMIN HYDROCHLORIDE)
1GM
Marketing Status: Prescription
Active Ingredient: METFORMIN HYDROCHLORIDE
Proprietary Name: GLUMETZA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB3
Application Number: N021748
Product Number: 002
Approval Date: Jun 3, 2005
Applicant Holder Full Name: SANTARUS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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