Details for New Drug Application (NDA): 074686
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The generic ingredient in GLYBURIDE (MICRONIZED) is glyburide. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the glyburide profile page.
Summary for 074686
Tradename: | GLYBURIDE (MICRONIZED) |
Applicant: | Teva |
Ingredient: | glyburide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 074686
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLYBURIDE (MICRONIZED) | glyburide | TABLET;ORAL | 074686 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-8034 | 0093-8034-01 | 100 TABLET in 1 BOTTLE (0093-8034-01) |
GLYBURIDE (MICRONIZED) | glyburide | TABLET;ORAL | 074686 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-8035 | 0093-8035-01 | 100 TABLET in 1 BOTTLE (0093-8035-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.5MG | ||||
Approval Date: | Apr 20, 1999 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG | ||||
Approval Date: | Apr 20, 1999 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4.5MG | ||||
Approval Date: | Apr 20, 1999 | TE: | RLD: | No |
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