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FDA ANDA · ANDA088205

CYPROHEPTADINE HYDROCHLORIDE

Sponsor: PLIVA

APPLICATION
ANDA088205
TYPE
ANDA
ORIGINAL APPROVAL
1983-07-26
LATEST ACTION
2002-09-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CYPROHEPTADINE HYDROCHLORIDEDiscontinued
CYPROHEPTADINE HYDROCHLORIDE 4MG · TABLET · ORAL

Approval history

2002-09-05Labeling · Supplement 16AP
2002-05-06Manufacturing (CMC) · Supplement 14AP
2002-05-06Manufacturing (CMC) · Supplement 12AP
2002-05-06Manufacturing (CMC) · Supplement 15AP
2001-10-01Labeling · Supplement 11AP
2000-07-07Manufacturing (CMC) · Supplement 10AP
1994-05-11Manufacturing (CMC) · Supplement 8AP
1988-06-07Manufacturing (CMC) · Supplement 7AP
1986-08-05Manufacturing (CMC) · Supplement 4AP
1985-06-19Manufacturing (CMC) · Supplement 2AP
1985-06-19Manufacturing (CMC) · Supplement 3AP
1985-06-19Manufacturing (CMC) · Supplement 1AP
1983-07-26OriginalAP
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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