← FDA DRUG APPROVALS

FDA ANDA · ANDA207229

AMAZON BASIC CARE ACETAMINOPHEN

acetaminophen

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA207229
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-09
LATEST ACTION
2023-04-13
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter

Products

ACETAMINOPHENOver-the-counter
ACETAMINOPHEN 650MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2023-04-13Labeling · Supplement 13 · standardAP
2023-04-13Labeling · Supplement 9 · standardAP
2023-04-13Labeling · Supplement 14 · standardAP
2023-04-13Labeling · Supplement 10 · standardAP
2016-11-09UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →