Details for New Drug Application (NDA): 079009
✉ Email this page to a colleague
The generic ingredient in GLYBURIDE AND METFORMIN HYDROCHLORIDE is glyburide; metformin hydrochloride. There are twenty drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.
Summary for 079009
Tradename: | GLYBURIDE AND METFORMIN HYDROCHLORIDE |
Applicant: | Heritage |
Ingredient: | glyburide; metformin hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 079009
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLYBURIDE AND METFORMIN HYDROCHLORIDE | glyburide; metformin hydrochloride | TABLET;ORAL | 079009 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-233 | 23155-233-01 | 100 TABLET in 1 BOTTLE (23155-233-01) |
GLYBURIDE AND METFORMIN HYDROCHLORIDE | glyburide; metformin hydrochloride | TABLET;ORAL | 079009 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-233 | 23155-233-05 | 500 TABLET in 1 BOTTLE (23155-233-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.25MG;250MG | ||||
Approval Date: | Jun 3, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG;500MG | ||||
Approval Date: | Jun 3, 2009 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG;500MG | ||||
Approval Date: | Jun 3, 2009 | TE: | AB | RLD: | No |
Complete Access Available with Subscription