Details for New Drug Application (NDA): 078905
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NDA 078905 describes GLIPIZIDE AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Dash Pharms, Epic Pharma Llc, Heritage, Sun Pharm Inds Inc, Teva Pharms, and Zydus Pharms Usa Inc, and is included in six NDAs. It is available from nine suppliers. Additional details are available on the GLIPIZIDE AND METFORMIN HYDROCHLORIDE profile page.
The generic ingredient in GLIPIZIDE AND METFORMIN HYDROCHLORIDE is glipizide; metformin hydrochloride. There are eighteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the glipizide; metformin hydrochloride profile page.
The generic ingredient in GLIPIZIDE AND METFORMIN HYDROCHLORIDE is glipizide; metformin hydrochloride. There are eighteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the glipizide; metformin hydrochloride profile page.
Summary for 078905
| Tradename: | GLIPIZIDE AND METFORMIN HYDROCHLORIDE |
| Applicant: | Zydus Pharms Usa Inc |
| Ingredient: | glipizide; metformin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078905
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLIPIZIDE AND METFORMIN HYDROCHLORIDE | glipizide; metformin hydrochloride | TABLET;ORAL | 078905 | ANDA | A-S Medication Solutions | 50090-2492 | 50090-2492-0 | 180 TABLET, FILM COATED in 1 BOTTLE (50090-2492-0) |
| GLIPIZIDE AND METFORMIN HYDROCHLORIDE | glipizide; metformin hydrochloride | TABLET;ORAL | 078905 | ANDA | A-S Medication Solutions | 50090-2556 | 50090-2556-0 | 180 TABLET, FILM COATED in 1 BOTTLE (50090-2556-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG;250MG | ||||
| Approval Date: | Jan 31, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG;500MG | ||||
| Approval Date: | Jan 31, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG;500MG | ||||
| Approval Date: | Jan 31, 2011 | TE: | AB | RLD: | No | ||||
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