Details for New Drug Application (NDA): 074388
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The generic ingredient in GLYBURIDE is glyburide; metformin hydrochloride. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.
Suppliers and Packaging for NDA: 074388
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLYBURIDE | glyburide | TABLET;ORAL | 074388 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-8342 | 0093-8342-01 | 100 TABLET in 1 BOTTLE (0093-8342-01) |
GLYBURIDE | glyburide | TABLET;ORAL | 074388 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-8343 | 0093-8343-01 | 100 TABLET in 1 BOTTLE (0093-8343-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.25MG | ||||
Approval Date: | Aug 29, 1995 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Aug 29, 1995 | TE: | AB1 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Aug 29, 1995 | TE: | AB1 | RLD: | No |
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