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FDA ANDA · ANDA091313

OXYCODONE HYDROCHLORIDE

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA091313
TYPE
ANDA
ORIGINAL APPROVAL
2011-02-18
LATEST ACTION
2018-09-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 10MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 15MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 20MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 30MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2018-09-18REMS · Supplement 6AP
2017-06-01Labeling · Supplement 5 · standardAP
2016-03-24Manufacturing (CMC) · Supplement 1AP
2011-02-18Original — REMS ↗AP
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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