Application 017407
- Type
- NDA
- Sponsor
- BOEHRINGER INGELHEIM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CATAPRES | CLONIDINE HYDROCHLORIDE | TABLET;ORAL | 0.1MG | Yes | No |
| 002 | CATAPRES | CLONIDINE HYDROCHLORIDE | TABLET;ORAL | 0.2MG | Yes | No |
| 003 | CATAPRES | CLONIDINE HYDROCHLORIDE | TABLET;ORAL | 0.3MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0597-0006 | Catapres | clonidine hydrochloride | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 0597-0006 | Catapres | clonidine hydrochloride | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 0597-0007 | Catapres | clonidine hydrochloride | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 0597-0007 | Catapres | clonidine hydrochloride | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 0597-0011 | Catapres | clonidine hydrochloride | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 0597-0011 | Catapres | clonidine hydrochloride | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 10985 | SUPPL | 2012-06-06 |
| 13132 | SUPPL | 2012-06-05 |
| 10984 | SUPPL | 2010-04-19 |
| 13131 | SUPPL | 2010-04-09 |
| 33260 | SUPPL | 2010-01-08 |
| 577 | SUPPL | 2010-01-06 |
| 576 | SUPPL | 2010-01-06 |
| 10983 | SUPPL | 2009-11-13 |