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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074612
Company: DIFGEN PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NICOTINE NICOTINE 21MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Over-the-counter None No No
NICOTINE NICOTINE 7MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Over-the-counter None No No
NICOTINE NICOTINE 14MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Over-the-counter None No 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
10/20/1997 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/13/2015 SUPPL-25 Labeling-Package Insert

Label is not available on this site.
02/16/2010 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
02/27/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
10/30/2007 SUPPL-7 Labeling

Label is not available on this site.
02/15/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
02/15/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
05/24/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
05/24/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
05/24/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
05/24/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

NICOTINE

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
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