Details for New Drug Application (NDA): 203499
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NDA 203499 describes GLIPIZIDE, which is a drug marketed by Aurobindo Pharma, Endo Operations, Norvium Bioscience, Unique, Watson Labs, Zydus Pharms, Accord Hlthcare, Ani Pharms, Apotex, Aurobindo Pharma Usa, Barr Labs Inc, Chartwell Rx, Oxford Pharms, Rubicon, Sandoz, Sun Pharm Inds Inc, Watson Labs Teva, Dash Pharms, Epic Pharma Llc, Heritage, Teva Pharms, and Zydus Pharms Usa Inc, and is included in twenty-six NDAs. It is available from forty 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 203499
| Tradename: | GLIPIZIDE |
| Applicant: | Zydus Pharms |
| Ingredient: | glipizide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203499
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLIPIZIDE | glipizide | TABLET, EXTENDED RELEASE;ORAL | 203499 | ANDA | Northstar Rx LLC. | 16714-894 | 16714-894-01 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-894-01) |
| GLIPIZIDE | glipizide | TABLET, EXTENDED RELEASE;ORAL | 203499 | ANDA | Northstar Rx LLC. | 16714-895 | 16714-895-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-895-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Jul 16, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
| Approval Date: | Jul 16, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | Jul 16, 2018 | TE: | AB | RLD: | No | ||||
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