Details for New Drug Application (NDA): 213356
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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 213356
Tradename: | METFORMIN HYDROCHLORIDE |
Applicant: | Apotex |
Ingredient: | metformin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 213356
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 213356 | ANDA | Apotex Corp. | 60505-4700 | 60505-4700-1 | 100 TABLET in 1 BOTTLE (60505-4700-1) |
METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 213356 | ANDA | Apotex Corp. | 60505-4701 | 60505-4701-9 | 90 TABLET in 1 BOTTLE (60505-4701-9) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Dec 13, 2021 | TE: | AB3 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1GM | ||||
Approval Date: | Dec 13, 2021 | TE: | AB3 | RLD: | No |
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