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FDA ANDA · ANDA210079

OXYCODONE AND ACETAMINOPHEN

Sponsor: NESHER PHARMS

APPLICATION
ANDA210079
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-28
LATEST ACTION
2021-03-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

OXYCODONE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 7.5MG · TABLET · ORAL
OXYCODONE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 2.5MG · TABLET · ORAL
OXYCODONE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 10MG · TABLET · ORAL
OXYCODONE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2021-03-04Labeling · Supplement 4 · standardAP
2019-10-11Labeling · Supplement 3 · standardAP
2018-09-20Labeling · Supplement 2 · standardAP
2018-09-18REMS · Supplement 1AP
2017-12-28UNKNOWN · Original · standardAP
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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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