Details for New Drug Application (NDA): 202298
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NDA 202298 describes GLIPIZIDE, which is a drug marketed by Aurobindo Pharma, Endo Operations, Norvium Bioscience, Unique, Watson Labs, Zydus Pharms, Accord Hlthcare, Aiping Pharm Inc, Ani Pharms, Apotex, Aurobindo Pharma Usa, Barr Labs Inc, Chartwell Rx, Oxford Pharms, Rubicon, Sun Pharm Inds Inc, Watson Labs Teva, Epic Pharma Llc, Esjay Pharma, Heritage, Teva Pharms, and Zydus Pharms Usa Inc, and is included in twenty-six NDAs. It is available from thirty-six 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 202298
| Tradename: | GLIPIZIDE |
| Applicant: | Norvium Bioscience |
| Ingredient: | glipizide |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 202298
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 2.5MG | ||||
| Approval Date: | May 19, 2015 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
| Approval Date: | May 19, 2015 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | May 19, 2015 | TE: | RLD: | No | |||||
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