Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204794
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 | GUM, CHEWING;BUCCAL | 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 |
---|---|---|---|---|---|---|---|
05/10/2016 | ORIG-1 | Approval | STANDARD |
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.
GUM, CHEWING;BUCCAL; EQ 2MG BASE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
NICORETTE | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | Yes | 018612 | HALEON US HOLDINGS |
NICORETTE (MINT) | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | Yes | 018612 | HALEON US HOLDINGS |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 076775 | L PERRIGO CO |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 076777 | L PERRIGO CO |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 074507 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 076569 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 078699 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 079044 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 079216 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 204794 | P AND L |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 078325 | PERRIGO R AND D |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 078547 | PERRIGO R AND D |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 091349 | PERRIGO R AND D |
NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING;BUCCAL | Over-the-counter | No | 206394 | PERRIGO R AND D |