Details for New Drug Application (NDA): 206749
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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.
Summary for 206749
Tradename: | GLYBURIDE |
Applicant: | Zydus Pharms |
Ingredient: | glyburide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 206749
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLYBURIDE | glyburide | TABLET;ORAL | 206749 | ANDA | Zydus Lifesciences Limited | 65841-832 | 65841-832-01 | 100 TABLET in 1 BOTTLE (65841-832-01) |
GLYBURIDE | glyburide | TABLET;ORAL | 206749 | ANDA | Zydus Lifesciences Limited | 65841-832 | 65841-832-05 | 500 TABLET in 1 BOTTLE (65841-832-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.25MG | ||||
Approval Date: | May 10, 2016 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | May 10, 2016 | TE: | AB1 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | May 10, 2016 | TE: | AB1 | RLD: | No |
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