Details for New Drug Application (NDA): 078195
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NDA 078195 describes NEVIRAPINE, which is a drug marketed by Aurobindo, Cipla, Alvogen, Apotex, Aurobindo Pharma, Macleods Pharms Ltd, Mylan, Norvium Bioscience, Sandoz, Tech Organized, Apotex Inc, Hetero Labs Ltd Iii, Micro Labs Ltd, Mylan Pharms Inc, Prinston Inc, and Strides Pharma, and is included in twenty-three NDAs. It is available from seven suppliers. Additional details are available on the NEVIRAPINE profile page.
The generic ingredient in NEVIRAPINE is nevirapine. There are twenty drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the nevirapine profile page.
The generic ingredient in NEVIRAPINE is nevirapine. There are twenty drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the nevirapine profile page.
Summary for 078195
| Tradename: | NEVIRAPINE |
| Applicant: | Strides Pharma |
| Ingredient: | nevirapine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078195
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEVIRAPINE | nevirapine | TABLET;ORAL | 078195 | ANDA | Strides Pharma Science Limited | 64380-709 | 64380-709-03 | 60 TABLET in 1 BOTTLE, PLASTIC (64380-709-03) |
| NEVIRAPINE | nevirapine | TABLET;ORAL | 078195 | ANDA | Amneal Pharmaceuticals LLC | 65162-209 | 65162-209-06 | 60 TABLET in 1 BOTTLE (65162-209-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | May 22, 2012 | TE: | AB | RLD: | No | ||||
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