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FDA ANDA · ANDA077827

OXANDROLONE

Sponsor: PAR PHARM

APPLICATION
ANDA077827
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-22
LATEST ACTION
2007-12-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

OXANDROLONEDiscontinued
OXANDROLONE 10MG · TABLET · ORAL
OXANDROLONEDiscontinued
OXANDROLONE 2.5MG · TABLET · ORAL

Approval history

2007-12-31Labeling · Supplement 1LetterAP
2007-06-22OriginalAP
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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