Drugs@FDA: FDA-Approved Drugs
Company: PPI-DAC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | None | No | No |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | 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 |
---|---|---|---|---|---|---|---|
10/09/2012 | 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 |
---|---|---|---|---|---|
12/27/2019 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
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11/01/2018 | SUPPL-18 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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11/01/2018 | SUPPL-17 | Labeling, Labeling-Container/Carton Labels |
Label is not available on this site. |
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01/14/2016 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
01/14/2016 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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01/14/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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06/30/2014 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
NICOTINE POLACRILEX
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TROCHE/LOZENGE;ORAL; EQ 4MG BASE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
NICORETTE | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | Yes | 021330 | HALEON US HOLDINGS |
NICORETTE | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | Yes | 022360 | HALEON US HOLDINGS |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 213266 | AUROBINDO PHARMA |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 215357 | AUROBINDO PHARMA LTD |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 212796 | DR REDDYS LABS SA |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 212983 | DR REDDYS LABS SA |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 213233 | DR REDDYS LABS SA |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 208875 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 209206 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 209519 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 209520 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 210711 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 210712 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 212056 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 212057 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 077007 | PERRIGO R AND D |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 090821 | PERRIGO R AND D |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 207868 | PLD ACQUISITIONS |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 090711 | PPI-DAC |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 203690 | PPI-DAC |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TROCHE/LOZENGE;ORAL; EQ 2MG BASE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
NICORETTE | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | Yes | 021330 | HALEON US HOLDINGS |
NICORETTE | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | Yes | 022360 | HALEON US HOLDINGS |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 213266 | AUROBINDO PHARMA |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 215357 | AUROBINDO PHARMA LTD |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 212796 | DR REDDYS LABS SA |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 212983 | DR REDDYS LABS SA |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 213233 | DR REDDYS LABS SA |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 208875 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 209206 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 209519 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 209520 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 210711 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 210712 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 212056 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 212057 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 077007 | PERRIGO R AND D |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 090821 | PERRIGO R AND D |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 207868 | PLD ACQUISITIONS |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 090711 | PPI-DAC |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE;ORAL | Over-the-counter | No | 203690 | PPI-DAC |