Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018891
Company: LAVIPHARM
Company: LAVIPHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CATAPRES-TTS-1 | CLONIDINE | 0.1MG/24HR | SYSTEM;TRANSDERMAL | Prescription | AB | Yes | No |
| CATAPRES-TTS-2 | CLONIDINE | 0.2MG/24HR | SYSTEM;TRANSDERMAL | Prescription | AB | Yes | No |
| CATAPRES-TTS-3 | CLONIDINE | 0.3MG/24HR | SYSTEM;TRANSDERMAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/10/1984 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/01/2023 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018891Orig1s032correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018891Orig1s032correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018891Orig1s032ltr.pdf | |
| 05/31/2012 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018891s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018891s028ltr.pdf | |
| 04/28/2010 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018891s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018891s027ltr.pdf | |
| 11/13/2009 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018891s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018891s025ltr.pdf | |
| 04/13/2006 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018891s024ltr.pdf |
| 08/13/2004 | SUPPL-22 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18891s022ltr.pdf |
| 08/30/1999 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/1998 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/03/1997 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1996 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/23/1996 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/06/1996 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 09/06/1996 | SUPPL-15 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018891-S15_Catapres-TTS_toc.cfm |
| 02/19/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/24/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 12/07/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/27/1988 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1988 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/14/1987 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/11/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/18/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/18/1985 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/01/2023 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018891Orig1s032correctedlbl.pdf | |
| 05/31/2012 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018891s028lbl.pdf | |
| 04/28/2010 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018891s027lbl.pdf | |
| 11/13/2009 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018891s025lbl.pdf |
CATAPRES-TTS-1
SYSTEM;TRANSDERMAL; 0.1MG/24HR
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CATAPRES-TTS-1 | CLONIDINE | 0.1MG/24HR | SYSTEM;TRANSDERMAL | Prescription | Yes | AB | 018891 | LAVIPHARM |
| CLONIDINE | CLONIDINE | 0.1MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 090873 | ACTAVIS LABS UT INC |
| CLONIDINE | CLONIDINE | 0.1MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 076157 | AVEVA |
| CLONIDINE | CLONIDINE | 0.1MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 079090 | DR REDDYS LABS SA |
| CLONIDINE | CLONIDINE | 0.1MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 076166 | MYLAN TECHNOLOGIES |
CATAPRES-TTS-2
SYSTEM;TRANSDERMAL; 0.2MG/24HR
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CATAPRES-TTS-2 | CLONIDINE | 0.2MG/24HR | SYSTEM;TRANSDERMAL | Prescription | Yes | AB | 018891 | LAVIPHARM |
| CLONIDINE | CLONIDINE | 0.2MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 090873 | ACTAVIS LABS UT INC |
| CLONIDINE | CLONIDINE | 0.2MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 076157 | AVEVA |
| CLONIDINE | CLONIDINE | 0.2MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 079090 | DR REDDYS LABS SA |
| CLONIDINE | CLONIDINE | 0.2MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 076166 | MYLAN TECHNOLOGIES |
CATAPRES-TTS-3
SYSTEM;TRANSDERMAL; 0.3MG/24HR
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CATAPRES-TTS-3 | CLONIDINE | 0.3MG/24HR | SYSTEM;TRANSDERMAL | Prescription | Yes | AB | 018891 | LAVIPHARM |
| CLONIDINE | CLONIDINE | 0.3MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 090873 | ACTAVIS LABS UT INC |
| CLONIDINE | CLONIDINE | 0.3MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 076157 | AVEVA |
| CLONIDINE | CLONIDINE | 0.3MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 079090 | DR REDDYS LABS SA |
| CLONIDINE | CLONIDINE | 0.3MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 076166 | MYLAN TECHNOLOGIES |