Details for New Drug Application (NDA): 217631
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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 217631
Tradename: | METFORMIN HYDROCHLORIDE |
Applicant: | Laurus |
Ingredient: | metformin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 217631
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 217631 | ANDA | Laurus Labs Limited | 42385-977 | 42385-977-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-01) |
METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 217631 | ANDA | Laurus Labs Limited | 42385-977 | 42385-977-05 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Oct 5, 2023 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 750MG | ||||
Approval Date: | Oct 5, 2023 | TE: | AB | RLD: | No |
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