Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208875
Company: P AND L
Company: P AND L
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 |
---|---|---|---|---|---|---|---|
10/31/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208875Orig1s000TAltr.pdf |
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 |