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FDA ANDA · ANDA083125

PROPOXYPHENE HYDROCHLORIDE

Sponsor: SANDOZ

APPLICATION
ANDA083125
TYPE
ANDA
ORIGINAL APPROVAL
1972-10-18
LATEST ACTION
1998-10-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PROPOXYPHENE HYDROCHLORIDEDiscontinued
PROPOXYPHENE HYDROCHLORIDE 65MG · CAPSULE · ORAL

Approval history

1998-10-14Manufacturing (CMC) · Supplement 79AP
1990-08-31Labeling · Supplement 78AP
1989-01-06Labeling · Supplement 77AP
1988-01-15Manufacturing (CMC) · Supplement 76AP
1988-01-15Manufacturing (CMC) · Supplement 75AP
1987-06-09Manufacturing (CMC) · Supplement 73AP
1987-04-29Manufacturing (CMC) · Supplement 72AP
1987-01-15Manufacturing (CMC) · Supplement 71AP
1984-02-15Manufacturing (CMC) · Supplement 69AP
1984-02-15Manufacturing (CMC) · Supplement 67AP
1983-08-11Manufacturing (CMC) · Supplement 66AP
1983-08-11Manufacturing (CMC) · Supplement 64AP
1983-08-11Manufacturing (CMC) · Supplement 65AP
1982-08-09Manufacturing (CMC) · Supplement 60AP
1982-08-09Manufacturing (CMC) · Supplement 55AP
1982-06-10Manufacturing (CMC) · Supplement 52AP
1982-06-10Manufacturing (CMC) · Supplement 59AP
1982-06-10Manufacturing (CMC) · Supplement 57AP
1972-10-18OriginalAP
VIEW ON DRUGS@FDA ↗

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