Application 201152
- Type
- NDA
- Sponsor
- BOEHRINGER INGELHEIM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VIRAMUNE XR | NEVIRAPINE | TABLET, EXTENDED RELEASE;ORAL | 400MG | Yes | Yes |
| 002 | VIRAMUNE XR | NEVIRAPINE | TABLET, EXTENDED RELEASE;ORAL | 100MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0597-0123 | Viramune | nevirapine | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0123 | Viramune | nevirapine | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0123 | Viramune | nevirapine | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0123 | Viramune | nevirapine | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0123 | Viramune | nevirapine | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |