Details for New Drug Application (NDA): 078584
NDA 078584 describes NEVIRAPINE, which is a drug marketed by Aurobindo, Cipla, Alvogen, Apotex, Aurobindo Pharma, Macleods Pharms, Mylan, Pharmobedient, 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 six suppliers. Additional details are available on the NEVIRAPINE profile page.
The generic ingredient in NEVIRAPINE is nevirapine. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the nevirapine profile page.
The generic ingredient in NEVIRAPINE is nevirapine. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the nevirapine profile page.
Summary for 078584
| Tradename: | NEVIRAPINE |
| Applicant: | Hetero Labs Ltd Iii |
| Ingredient: | nevirapine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078584
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEVIRAPINE | nevirapine | TABLET;ORAL | 078584 | ANDA | Camber Pharmaceuticals, Inc. | 31722-505 | 31722-505-01 | 100 TABLET in 1 BOTTLE (31722-505-01) |
| NEVIRAPINE | nevirapine | TABLET;ORAL | 078584 | ANDA | Camber Pharmaceuticals, Inc. | 31722-505 | 31722-505-05 | 500 TABLET in 1 BOTTLE (31722-505-05) |
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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