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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210712
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
09/06/2019 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.

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 090711 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 203690 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 207868 PLD ACQUISITIONS

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 090711 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 203690 PERRIGO R AND D
NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE;ORAL Over-the-counter No 207868 PLD ACQUISITIONS
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