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FDA ANDA · ANDA213266

AMAZON BASIC CARE NICOTINE POLACRILEX

nicotine polacrilex

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA213266
TYPE
ANDA
ORIGINAL APPROVAL
2021-08-03
LATEST ACTION
2023-09-21
ROUTE
ORAL
DOSAGE FORM
TROCHE/LOZENGE
MARKETING STATUS
Over-the-counter

Products

NICOTINE POLACRILEXOver-the-counter
NICOTINE POLACRILEX EQ 4MG BASE · TROCHE/LOZENGE · ORAL
NICOTINE POLACRILEXOver-the-counter
NICOTINE POLACRILEX EQ 2MG BASE · TROCHE/LOZENGE · ORAL

Approval history

2023-09-21Labeling · Supplement 1 · standardAP
2021-08-03UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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