Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020076
Company: DR REDDYS LABS SA
Company: DR REDDYS LABS SA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HABITROL | NICOTINE | 7MG/24HR | Film, Extended Release; Transdermal | Discontinued | None | No | No |
| HABITROL | NICOTINE | 14MG/24HR | Film, Extended Release; Transdermal | Discontinued | None | No | No |
| HABITROL | NICOTINE | 21MG/24HR | Film, Extended Release; Transdermal | Discontinued | None | No | No |
| HABITROL | NICOTINE | 7MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Over-the-counter | None | Yes | No |
| HABITROL | NICOTINE | 14MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Over-the-counter | None | Yes | No |
| HABITROL | NICOTINE | 21MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Over-the-counter | None | 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 |
|---|---|---|---|---|---|---|---|
| 11/27/1991 | 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 |
|---|---|---|---|---|---|
| 01/02/2019 | SUPPL-51 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020076Orig1s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020076Orig1s051ltr.pdf | |
| 06/27/2018 | SUPPL-49 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020076Orig1s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020076Orig1s049ltr.pdf | |
| 07/23/2017 | SUPPL-45 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020076Orig1s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020076Orig1s045ltr.pdf | |
| 07/05/2016 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020076Orig1s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020076Orig1s043ltr.pdf | |
| 07/06/2016 | SUPPL-42 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020076Orig1s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020076Orig1s042ltr.pdf | |
| 05/10/2016 | SUPPL-41 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/20076Orig1s041Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020076Orig1s041ltr.pdf | |
| 05/09/2016 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/04/2016 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/2016 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/17/2015 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/2014 | SUPPL-36 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020076Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020076Orig1s036ltr.pdf | |
| 05/16/2013 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/2006 | SUPPL-29 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020076s029ltr.pdf |
| 11/22/2005 | SUPPL-28 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020076s028ltr.pdf |
| 10/21/2004 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20076s027ltr.pdf |
| 01/21/2004 | SUPPL-25 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20076slr025ltr.pdf |
| 02/06/2004 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20076slr024ltr.pdf |
| 07/15/2002 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20076s21lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20076slr021ltr.pdf | |
| 07/12/2002 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20076s20lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20076slr020ltr.pdf | |
| 11/07/2000 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/31/2000 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1999 | SUPPL-13 | Efficacy-Accelerated Approval Confirmatory Study |
Label is not available on this site. |
||
| 11/12/1999 | SUPPL-11 | Efficacy-Rx To OTC Switch |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20076S11LTR.PDF |
| 10/06/1995 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/24/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/1992 | 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 |
|---|---|---|---|---|---|
| 01/02/2019 | SUPPL-51 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020076Orig1s051lbl.pdf | |
| 06/27/2018 | SUPPL-49 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020076Orig1s049lbl.pdf | |
| 07/23/2017 | SUPPL-45 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020076Orig1s045lbl.pdf | |
| 07/23/2017 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020076Orig1s045lbl.pdf | |
| 07/06/2016 | SUPPL-42 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020076Orig1s042lbl.pdf | |
| 07/05/2016 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020076Orig1s043lbl.pdf | |
| 05/10/2016 | SUPPL-41 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/20076Orig1s041Lbl.pdf | |
| 07/25/2014 | SUPPL-36 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020076Orig1s036lbl.pdf | |
| 07/15/2002 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20076s21lbl.pdf | |
| 07/12/2002 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20076s20lbl.pdf |
HABITROL
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
FILM, EXTENDED RELEASE;TRANSDERMAL; 7MG/24HR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| HABITROL | NICOTINE | 7MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Over-the-counter | Yes | 020076 | DR REDDYS LABS SA |
| NICODERM CQ | NICOTINE | 7MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Over-the-counter | Yes | 020165 | CHATTEM SANOFI |
| NICOTINE | NICOTINE | 7MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Over-the-counter | No | 074612 | DIFGEN PHARMS |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
FILM, EXTENDED RELEASE;TRANSDERMAL; 21MG/24HR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| HABITROL | NICOTINE | 21MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Over-the-counter | Yes | 020076 | DR REDDYS LABS SA |
| NICODERM CQ | NICOTINE | 21MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Over-the-counter | Yes | 020165 | CHATTEM SANOFI |
| NICOTINE | NICOTINE | 21MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Over-the-counter | No | 074612 | DIFGEN PHARMS |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
FILM, EXTENDED RELEASE;TRANSDERMAL; 14MG/24HR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| HABITROL | NICOTINE | 14MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Over-the-counter | Yes | 020076 | DR REDDYS LABS SA |
| NICODERM CQ | NICOTINE | 14MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Over-the-counter | Yes | 020165 | CHATTEM SANOFI |
| NICOTINE | NICOTINE | 14MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Over-the-counter | No | 074612 | DIFGEN PHARMS |