Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020076
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 SANOFI AVENTIS US
NICOTINE NICOTINE 7MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Over-the-counter No 074612 AVEVA

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 SANOFI AVENTIS US
NICOTINE NICOTINE 21MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Over-the-counter No 074612 AVEVA

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 SANOFI AVENTIS US
NICOTINE NICOTINE 14MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Over-the-counter No 074612 AVEVA

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