Details for New Drug Application (NDA): 078321
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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 078321
Tradename: | METFORMIN HYDROCHLORIDE |
Applicant: | Cspc Ouyi |
Ingredient: | metformin hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 078321
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 078321 | ANDA | Calvin Scott & Co., Inc. | 17224-311 | 17224-311-28 | 28 TABLET, EXTENDED RELEASE in 1 BOTTLE (17224-311-28) |
METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 078321 | ANDA | AvPAK | 50268-550 | 50268-550-15 | 50 BLISTER PACK in 1 BOX (50268-550-15) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-550-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Apr 17, 2008 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 750MG | ||||
Approval Date: | Apr 17, 2008 | TE: | AB | RLD: | No |
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