Application 018891
- Type
- NDA
- Sponsor
- BOEHRINGER INGELHEIM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CATAPRES-TTS-1 | CLONIDINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.1MG/24HR | Yes | No |
| 002 | CATAPRES-TTS-2 | CLONIDINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.2MG/24HR | Yes | No |
| 003 | CATAPRES-TTS-3 | CLONIDINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.3MG/24HR | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0597-0031 | Catapres-TTS | clonidine | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 0597-0031 | Catapres-TTS | clonidine | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 0597-0031 | Catapres-TTS | clonidine | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 0597-0031 | Catapres-TTS | clonidine | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 0597-0032 | Catapres-TTS | clonidine | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 0597-0032 | Catapres-TTS | clonidine | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 0597-0032 | Catapres-TTS | clonidine | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 0597-0032 | Catapres-TTS | clonidine | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 0597-0033 | Catapres-TTS | clonidine | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 0597-0033 | Catapres-TTS | clonidine | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 0597-0033 | Catapres-TTS | clonidine | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 0597-0033 | Catapres-TTS | clonidine | Boehringer Ingelheim Pharmaceuticals Inc. | NDA | Current |
| 21695-567 | Catapres | clonidine | Rebel Distributors Corp | NDA | Current |
| 82089-101 | Catapres-TTS-1 | clonidine | Technomed Inc. | NDA | Current |
| 82089-101 | Catapres-TTS-1 | clonidine | Technomed Inc. | NDA | Current |
| 82089-102 | Catapres-TTS-2 | clonidine | Technomed Inc. | NDA | Current |
| 82089-102 | Catapres-TTS-2 | clonidine | Technomed Inc. | NDA | Current |
| 82089-103 | Catapres-TTS-3 | clonidine | Technomed Inc. | NDA | Current |
| 82089-103 | Catapres-TTS-3 | clonidine | Technomed Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 73380 | SUPPL | 2023-02-06 |
| 73376 | SUPPL | 2023-02-03 |
| 73370 | SUPPL | 2023-02-02 |
| 16084 | SUPPL | 2012-06-07 |
| 11358 | SUPPL | 2012-06-06 |
| 33636 | SUPPL | 2010-05-07 |
| 16083 | SUPPL | 2010-05-03 |
| 1119 | SUPPL | 2010-01-07 |
| 11357 | SUPPL | 2009-11-13 |
| 16082 | SUPPL | 2006-04-14 |
| 1118 | SUPPL | 2004-08-25 |
| 20162 | SUPPL | 2003-08-05 |