Details for New Drug Application (NDA): 078083
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NDA 078083 describes GLIPIZIDE AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Epic Pharma Llc, Heritage, Novitium Pharma, 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 is one drug master file entry 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 is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the glipizide; metformin hydrochloride profile page.
Summary for 078083
| Tradename: | GLIPIZIDE AND METFORMIN HYDROCHLORIDE |
| Applicant: | Novitium Pharma |
| Ingredient: | glipizide; metformin hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2.5MG;250MG | ||||
| Approval Date: | Apr 12, 2007 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2.5MG;500MG | ||||
| Approval Date: | Apr 12, 2007 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG;500MG | ||||
| Approval Date: | Apr 12, 2007 | TE: | RLD: | No | |||||
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