APPLICATION
ANDA089775
TYPE
ANDA
ORIGINAL APPROVAL
1989-01-12
LATEST ACTION
2001-06-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ROXICET 5/500Discontinued
ACETAMINOPHEN 500MG, OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2001-06-01Labeling · Supplement 10AP
1999-04-13Manufacturing (CMC) · Supplement 9AP
1996-08-28Manufacturing (CMC) · Supplement 8AP
1995-06-23Manufacturing (CMC) · Supplement 6AP
1995-06-23Manufacturing (CMC) · Supplement 7AP
1994-07-25Manufacturing (CMC) · Supplement 5AP
1992-05-07Labeling · Supplement 4AP
1989-05-15Manufacturing (CMC) · Supplement 2AP
1989-05-15Manufacturing (CMC) · Supplement 1AP
1989-01-12OriginalAP
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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