Details for New Drug Application (NDA): 209313
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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 209313
Tradename: | METFORMIN HYDROCHLORIDE |
Applicant: | Granules |
Ingredient: | metformin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 209313
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209313 | ANDA | A-S Medication Solutions | 50090-6516 | 50090-6516-0 | 90 TABLET in 1 BOTTLE (50090-6516-0) |
METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209313 | ANDA | Granules India Ltd | 62207-491 | 62207-491-31 | 5000 TABLET in 1 POUCH (62207-491-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Mar 16, 2018 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 750MG | ||||
Approval Date: | Mar 16, 2018 | TE: | AB | RLD: | No |
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