Details for New Drug Application (NDA): 077880
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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 077880
Tradename: | METFORMIN HYDROCHLORIDE |
Applicant: | Amneal Pharms Ny |
Ingredient: | metformin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 077880
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET;ORAL | 077880 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-527 | 43063-527-14 | 14 TABLET in 1 BOTTLE, PLASTIC (43063-527-14) |
METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET;ORAL | 077880 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-527 | 43063-527-20 | 20 TABLET in 1 BOTTLE, PLASTIC (43063-527-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Jun 5, 2006 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 850MG | ||||
Approval Date: | Jun 5, 2006 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
Approval Date: | Jun 5, 2006 | TE: | AB | RLD: | No |
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