Details for New Drug Application (NDA): 077911
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NDA 077911 describes GLIMEPIRIDE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Carlsbad, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma Pharms, Indoco Remedies, Micro Labs, Mylan, Norvium Bioscience, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Teva, and Watson Labs, and is included in seventeen NDAs. It is available from thirty-two suppliers. Additional details are available on the GLIMEPIRIDE profile page.
The generic ingredient in GLIMEPIRIDE is glimepiride. There are sixteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the glimepiride profile page.
The generic ingredient in GLIMEPIRIDE is glimepiride. There are sixteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the glimepiride profile page.
Summary for 077911
| Tradename: | GLIMEPIRIDE |
| Applicant: | Carlsbad |
| Ingredient: | glimepiride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 077911
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLIMEPIRIDE | glimepiride | TABLET;ORAL | 077911 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-697 | 43063-697-90 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-697-90) |
| GLIMEPIRIDE | glimepiride | TABLET;ORAL | 077911 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-697 | 43063-697-93 | 180 TABLET in 1 BOTTLE, PLASTIC (43063-697-93) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Sep 22, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Sep 22, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
| Approval Date: | Sep 22, 2009 | TE: | AB | RLD: | No | ||||
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