Drugs@FDA: FDA-Approved Drugs
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CATAPRES | CLONIDINE HYDROCHLORIDE | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CATAPRES | CLONIDINE HYDROCHLORIDE | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CATAPRES | CLONIDINE HYDROCHLORIDE | 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/03/1974 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/21/2015 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/2012 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017407s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017407s037ltr.pdf | |
| 04/07/2010 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017407s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017407s036ltr.pdf | |
| 11/09/2009 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017407s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017407s034ltr.pdf | |
| 01/05/2010 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017407s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017407s033ltr.pdf | |
| 04/13/1999 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1998 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/03/1997 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/02/1996 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 08/02/1996 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 06/20/1988 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 03/26/1987 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 09/02/1987 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/11/1986 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/02/1985 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 03/06/1985 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/06/1984 | SUPPL-20 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/08/1987 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 11/03/1982 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/1981 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/06/1981 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/20/1981 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/20/1981 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/12/1980 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/16/1980 | SUPPL-12 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 02/26/1980 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/10/1980 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/27/1978 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/20/1979 | SUPPL-8 | Efficacy |
Label is not available on this site. |
||
| 02/05/1981 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/10/1976 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/17/1977 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/27/1976 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/26/1976 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/08/1976 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/31/2012 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017407s037lbl.pdf | |
| 04/07/2010 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017407s036lbl.pdf | |
| 01/05/2010 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017407s033lbl.pdf | |
| 11/09/2009 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017407s034lbl.pdf |