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FDA ANDA · ANDA204092

OXYCODONE HYDROCHLORIDE

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA204092
TYPE
ANDA
ORIGINAL APPROVAL
2014-06-05
LATEST ACTION
2020-02-12
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 100MG/5ML · SOLUTION · ORAL

Approval history

2020-02-12Labeling · Supplement 7 · standardAP
2020-02-12Labeling · Supplement 5 · standardAP
2018-09-18REMS · Supplement 3AP
2014-06-05UNKNOWN · Original — REMS ↗AP
VIEW ON DRUGS@FDA ↗

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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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