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FDA ANDA · ANDA206394
TOPCARE NICOTINE
nicotine polacrilex
Sponsor: PERRIGO R AND D
APPLICATION
ANDA206394
TYPE
ANDA
ORIGINAL APPROVAL
2016-12-15
LATEST ACTION
2023-09-21
ROUTE
ORAL, BUCCAL
DOSAGE FORM
GUM, CHEWING
MARKETING STATUS
Over-the-counter
Products
NICOTINE POLACRILEXOver-the-counter
NICOTINE POLACRILEX EQ 2MG BASE · GUM, CHEWING · BUCCAL
Approval history
2023-09-21Labeling · Supplement 14 · standardAP
2022-01-06Manufacturing (CMC) · Supplement 13 · unknownAP
2020-04-24Manufacturing (CMC) · Supplement 9AP
2018-07-23Manufacturing (CMC) · Supplement 4 · unknownAP
2016-12-15UNKNOWN · 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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