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FDA ANDA · ANDA215357
AMAZON BASIC CARE NICOTINE POLACRILEX
nicotine polacrilex mini
Sponsor: AUROBINDO PHARMA LTD
APPLICATION
ANDA215357
TYPE
ANDA
ORIGINAL APPROVAL
2022-05-13
LATEST ACTION
2022-05-13
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
2022-05-13UNKNOWN · Original · standardAP
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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