Details for New Drug Application (NDA): 077095
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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 077095
Tradename: | METFORMIN HYDROCHLORIDE |
Applicant: | Aurobindo |
Ingredient: | metformin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 077095
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET;ORAL | 077095 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7982 | 0615-7982-05 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7982-05) |
METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET;ORAL | 077095 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7982 | 0615-7982-30 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-7982-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Jan 14, 2005 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 850MG | ||||
Approval Date: | Jan 14, 2005 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
Approval Date: | Jan 14, 2005 | TE: | AB | RLD: | No |
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