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FDA ANDA · ANDA062737

OXACILLIN SODIUM

Sponsor: SANDOZ

APPLICATION
ANDA062737
TYPE
ANDA
ORIGINAL APPROVAL
1986-12-23
LATEST ACTION
2016-05-25
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

OXACILLIN SODIUMDiscontinued
OXACILLIN SODIUM EQ 1GM BASE/VIAL · POWDER · INTRAVENOUS
OXACILLIN SODIUMDiscontinued
OXACILLIN SODIUM EQ 2GM BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2016-05-25Labeling · Supplement 17 · standardAP
2016-05-25Labeling · Supplement 13AP
2004-10-04Labeling · Supplement 5AP
1996-03-26Manufacturing (CMC) · Supplement 4AP
1992-10-30Manufacturing (CMC) · Supplement 2AP
1990-07-24Manufacturing (CMC) · Supplement 1AP
1986-12-23OriginalAP
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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