Details for New Drug Application (NDA): 078181
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NDA 078181 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 078181
| Tradename: | GLIMEPIRIDE |
| Applicant: | Accord Hlthcare |
| Ingredient: | glimepiride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078181
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GLIMEPIRIDE | glimepiride | TABLET;ORAL | 078181 | ANDA | Accord Healthcare Inc | 16729-001 | 16729-001-01 | 100 TABLET in 1 BOTTLE (16729-001-01) |
| GLIMEPIRIDE | glimepiride | TABLET;ORAL | 078181 | ANDA | Accord Healthcare Inc | 16729-001 | 16729-001-16 | 500 TABLET in 1 BOTTLE (16729-001-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Aug 23, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Aug 23, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
| Approval Date: | Aug 23, 2007 | TE: | AB | RLD: | No | ||||
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