Details for New Drug Application (NDA): 079118
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The generic ingredient in METFORMIN HYDROCHLORIDE is metformin hydrochloride; saxagliptin hydrochloride. There are forty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.
Summary for 079118
Tradename: | METFORMIN HYDROCHLORIDE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | metformin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 079118
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 079118 | ANDA | Aurobindo Pharma Limited | 59651-548 | 59651-548-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-548-01) |
METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 079118 | ANDA | Aurobindo Pharma Limited | 59651-548 | 59651-548-05 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-548-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Jul 20, 2012 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 750MG | ||||
Approval Date: | Jul 20, 2012 | TE: | AB | RLD: | No |
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