Drugs@FDA: FDA-Approved Drugs
Company: AVEVA
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. |
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02/16/2010 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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02/27/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/30/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |
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02/15/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/15/2000 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/24/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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05/24/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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05/24/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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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 | 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 | CHATTEM SANOFI |
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 | CHATTEM SANOFI |
NICOTINE | NICOTINE | 14MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Over-the-counter | No | 074612 | AVEVA |