Application 205832
- Type
- NDA
- Sponsor
- BOEHRINGER INGELHEIM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OFEV | NINTEDANIB ESYLATE | CAPSULE;ORAL | EQ 100MG BASE | Yes | No |
| 002 | OFEV | NINTEDANIB ESYLATE | CAPSULE;ORAL | EQ 150MG BASE | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0597-0143 | Ofev | nintedanib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0143 | Ofev | nintedanib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0143 | Ofev | nintedanib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0143 | Ofev | nintedanib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0143 | Ofev | nintedanib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0143 | Ofev | nintedanib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0145 | Ofev | nintedanib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0145 | Ofev | nintedanib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0145 | Ofev | nintedanib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0145 | Ofev | nintedanib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0145 | Ofev | nintedanib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0145 | Ofev | nintedanib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |