← FDA DRUG APPROVALS

FDA ANDA · ANDA091670

OXYCODONE AND ASPIRIN

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA091670
TYPE
ANDA
ORIGINAL APPROVAL
2011-03-16
LATEST ACTION
2021-04-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

OXYCODONE AND ASPIRINDiscontinued
ASPIRIN 325MG, OXYCODONE HYDROCHLORIDE 4.8355MG · TABLET · ORAL

Approval history

2021-04-28Labeling · Supplement 8 · standardAP
2021-03-04Labeling · Supplement 7 · standardAP
2021-02-26Labeling · Supplement 6 · standardAP
2019-10-08Labeling · Supplement 5 · standardAP
2018-09-20Labeling · Supplement 4 · standardAP
2018-09-18REMS · Supplement 2AP
2011-03-16Original — REMS ↗AP
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 →