Application 214358
- Type
- NDA
- Sponsor
- BOEHRINGER INGELHEIM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PRADAXA | DABIGATRAN | PELLETS;ORAL | 20MG | No | No |
| 002 | PRADAXA | DABIGATRAN | PELLETS;ORAL | 30MG | No | No |
| 003 | PRADAXA | DABIGATRAN | PELLETS;ORAL | 40MG | No | No |
| 004 | PRADAXA | DABIGATRAN | PELLETS;ORAL | 50MG | No | No |
| 005 | PRADAXA | DABIGATRAN | PELLETS;ORAL | 110MG | No | No |
| 006 | PRADAXA | DABIGATRAN | PELLETS;ORAL | 150MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0597-0425 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0425 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0425 | Pradaxa | DABIGATRAN ETEXILATE MESYLATE | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0430 | Pradaxa | DABIGATRAN ETEXILATE MESYLATE | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0430 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0430 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0435 | Pradaxa | DABIGATRAN ETEXILATE MESYLATE | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0435 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0435 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0440 | Pradaxa | DABIGATRAN ETEXILATE MESYLATE | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0440 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0440 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0445 | Pradaxa | DABIGATRAN ETEXILATE MESYLATE | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0445 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0445 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0450 | Pradaxa | DABIGATRAN ETEXILATE MESYLATE | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0450 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0450 | Pradaxa | dabigatran etexilate | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83643 | SUPPL | 2025-10-03 |
| 82604 | SUPPL | 2025-10-03 |
| 82605 | SUPPL | 2025-06-20 |
| 76575 | SUPPL | 2023-11-15 |
| 76570 | SUPPL | 2023-11-15 |
| 70698 | SUPPL | 2022-04-05 |
| 70697 | SUPPL | 2022-04-05 |
| 70678 | ORIG | 2022-04-01 |
| 70630 | SUPPL | 2022-03-28 |
| 67871 | ORIG | 2021-06-23 |
| 67847 | ORIG | 2021-06-22 |
| 67846 | ORIG | 2021-06-22 |