Details for New Drug Application (NDA): 078596
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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 078596
Tradename: | METFORMIN HYDROCHLORIDE |
Applicant: | Amneal Pharms Ny |
Ingredient: | metformin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 078596
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 078596 | ANDA | AvKARE | 42291-497 | 42291-497-10 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-10) |
METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 078596 | ANDA | AvKARE | 42291-497 | 42291-497-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Jan 3, 2008 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 750MG | ||||
Approval Date: | Jan 3, 2008 | TE: | AB | RLD: | No |
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