Application 012836
- Type
- NDA
- Sponsor
- BOEHRINGER INGELHEIM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 003 | PERSANTINE | DIPYRIDAMOLE | TABLET;ORAL | 25MG | Yes | No |
| 004 | PERSANTINE | DIPYRIDAMOLE | TABLET;ORAL | 50MG | Yes | No |
| 005 | PERSANTINE | DIPYRIDAMOLE | TABLET;ORAL | 75MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0597-0017 | Persantine | dipyridamole | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0017 | Persantine | dipyridamole | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0018 | Persantine | dipyridamole | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0018 | Persantine | dipyridamole | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0019 | Persantine | dipyridamole | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0019 | Persantine | dipyridamole | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 68151-2996 | Dipyridamole | Dipyridamole | Carilion Materials Management | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 61247 | SUPPL | 2019-12-12 |
| 61246 | SUPPL | 2019-12-12 |
| 33096 | SUPPL | 2005-08-03 |
| 345 | SUPPL | 2005-08-03 |
| 12038 | SUPPL | 2004-08-06 |