Details for New Drug Application (NDA): 074378
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NDA 074378 describes GLIPIZIDE, which is a drug marketed by Aurobindo Pharma, Ph Health, Pharmobedient, Unique, Watson Labs, Zydus Pharms, Accord Hlthcare, Aiping Pharm Inc, Ani Pharms, Apotex, Aurobindo Pharma Usa, Barr Labs Inc, Chartwell Rx, Graviti Pharms, Oxford Pharms, Rubicon Research, Sun Pharm Inds Inc, Watson Labs Teva, Epic Pharma Llc, Heritage, Novitium Pharma, Teva Pharms, and Zydus Pharms Usa Inc, and is included in twenty-seven NDAs. It is available from thirty-one suppliers. Additional details are available on the GLIPIZIDE profile page.
The generic ingredient in GLIPIZIDE 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 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 074378
| Tradename: | GLIPIZIDE |
| Applicant: | Oxford Pharms |
| Ingredient: | glipizide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 074378
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLIPIZIDE | glipizide | TABLET;ORAL | 074378 | ANDA | Preferred Pharmaceuticals Inc. | 68788-4061 | 68788-4061-1 | 100 TABLET in 1 BOTTLE (68788-4061-1) |
| GLIPIZIDE | glipizide | TABLET;ORAL | 074378 | ANDA | Preferred Pharmaceuticals Inc. | 68788-4061 | 68788-4061-3 | 30 TABLET in 1 BOTTLE (68788-4061-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Nov 28, 1994 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Nov 28, 1994 | TE: | AB | RLD: | No | ||||
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