Application 201292
- Type
- NDA
- Sponsor
- BOEHRINGER INGELHEIM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GILOTRIF | AFATINIB DIMALEATE | TABLET;ORAL | EQ 20MG BASE | Yes | No |
| 002 | GILOTRIF | AFATINIB DIMALEATE | TABLET;ORAL | EQ 30MG BASE | Yes | No |
| 003 | GILOTRIF | AFATINIB DIMALEATE | TABLET;ORAL | EQ 40MG BASE | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0597-0137 | Gilotrif | afatinib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0137 | Gilotrif | afatinib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0137 | Gilotrif | afatinib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0137 | Gilotrif | afatinib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0138 | Gilotrif | afatinib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0138 | Gilotrif | afatinib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0138 | Gilotrif | afatinib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0138 | Gilotrif | afatinib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0141 | Gilotrif | afatinib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0141 | Gilotrif | afatinib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0141 | Gilotrif | afatinib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0141 | Gilotrif | afatinib | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |