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FDA ANDA · ANDA083101

PROPOXYPHENE COMPOUND-65

Sponsor: SANDOZ

APPLICATION
ANDA083101
TYPE
ANDA
ORIGINAL APPROVAL
1976-06-15
LATEST ACTION
1995-04-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PROPOXYPHENE COMPOUND-65Discontinued
ASPIRIN 389MG, CAFFEINE 32.4MG, PROPOXYPHENE HYDROCHLORIDE 65MG · CAPSULE · ORAL

Approval history

1995-04-04Manufacturing (CMC) · Supplement 66AP
1992-03-27Manufacturing (CMC) · Supplement 65AP
1991-06-14Manufacturing (CMC) · Supplement 62AP
1989-09-12Labeling · Supplement 64AP
1989-06-08Labeling · Supplement 63AP
1987-05-21Manufacturing (CMC) · Supplement 61AP
1987-05-21Manufacturing (CMC) · Supplement 60AP
1986-08-01Manufacturing (CMC) · Supplement 57AP
1986-08-01Manufacturing (CMC) · Supplement 58AP
1985-08-19Manufacturing (CMC) · Supplement 55AP
1985-06-24Manufacturing (CMC) · Supplement 51AP
1984-06-20Manufacturing (CMC) · Supplement 53AP
1984-06-20Manufacturing (CMC) · Supplement 54AP
1976-06-15OriginalAP
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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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