Details for New Drug Application (NDA): 206748
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The generic ingredient in GLYBURIDE AND METFORMIN HYDROCHLORIDE 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 206748
Tradename: | GLYBURIDE AND METFORMIN HYDROCHLORIDE |
Applicant: | Zydus Pharms |
Ingredient: | glyburide; metformin hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 206748
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLYBURIDE AND METFORMIN HYDROCHLORIDE | glyburide; metformin hydrochloride | TABLET;ORAL | 206748 | ANDA | Zydus Lifesciences Limited | 65841-824 | 65841-824-01 | 100 TABLET in 1 BOTTLE (65841-824-01) |
GLYBURIDE AND METFORMIN HYDROCHLORIDE | glyburide; metformin hydrochloride | TABLET;ORAL | 206748 | ANDA | Zydus Lifesciences Limited | 65841-824 | 65841-824-05 | 500 TABLET in 1 BOTTLE (65841-824-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.25MG;250MG | ||||
Approval Date: | Feb 29, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG;500MG | ||||
Approval Date: | Feb 29, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG;500MG | ||||
Approval Date: | Feb 29, 2016 | TE: | AB | RLD: | No |
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