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FDA ANDA · ANDA070443

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Sponsor: SANDOZ

APPLICATION
ANDA070443
TYPE
ANDA
ORIGINAL APPROVAL
1987-01-23
LATEST ACTION
2001-05-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 650MG, PROPOXYPHENE NAPSYLATE 100MG · TABLET · ORAL

Approval history

2001-05-15Manufacturing (CMC) · Supplement 20AP
1999-03-24Manufacturing (CMC) · Supplement 17AP
1996-09-23Manufacturing (CMC) · Supplement 19AP
1995-11-08Manufacturing (CMC) · Supplement 18AP
1994-06-07Manufacturing (CMC) · Supplement 16AP
1989-11-15Labeling · Supplement 15AP
1989-01-11Manufacturing (CMC) · Supplement 13AP
1988-07-21Labeling · Supplement 14AP
1987-07-09Manufacturing (CMC) · Supplement 10AP
1987-07-09Manufacturing (CMC) · Supplement 9AP
1987-07-09Manufacturing (CMC) · Supplement 11AP
1987-04-08Manufacturing (CMC) · Supplement 7AP
1987-04-08Manufacturing (CMC) · Supplement 8AP
1987-04-08Manufacturing (CMC) · Supplement 6AP
1987-02-20Manufacturing (CMC) · Supplement 5AP
1987-01-23OriginalAP
1987-01-06Manufacturing (CMC) · Supplement 4AP
1986-09-29Manufacturing (CMC) · Supplement 2AP
1986-09-29Manufacturing (CMC) · Supplement 1AP
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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