Details for New Drug Application (NDA): 203379
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The generic ingredient in GLYBURIDE 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 203379
Tradename: | GLYBURIDE |
Applicant: | Cadila Pharms Ltd |
Ingredient: | glyburide |
Patents: | 0 |
Suppliers and Packaging for NDA: 203379
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLYBURIDE | glyburide | TABLET;ORAL | 203379 | ANDA | A-S Medication Solutions | 50090-6196 | 50090-6196-0 | 30 TABLET in 1 BOTTLE (50090-6196-0) |
GLYBURIDE | glyburide | TABLET;ORAL | 203379 | ANDA | A-S Medication Solutions | 50090-6196 | 50090-6196-1 | 100 TABLET in 1 BOTTLE (50090-6196-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.25MG | ||||
Approval Date: | Jan 4, 2019 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Jan 4, 2019 | TE: | AB1 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jan 4, 2019 | TE: | AB1 | RLD: | No |
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