APPLICATION
ANDA080832
TYPE
ANDA
ORIGINAL APPROVAL
1972-11-03
LATEST ACTION
1997-04-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DIPHENHYDRAMINE HYDROCHLORIDEDiscontinued
DIPHENHYDRAMINE HYDROCHLORIDE 25MG · CAPSULE · ORAL
DIPHENHYDRAMINE HYDROCHLORIDEDiscontinued
DIPHENHYDRAMINE HYDROCHLORIDE 50MG · CAPSULE · ORAL
Approval history
1997-04-07Manufacturing (CMC) · Supplement 105AP
1995-01-10Manufacturing (CMC) · Supplement 104AP
1990-11-05Labeling · Supplement 103AP
1990-05-21Labeling · Supplement 102AP
1989-11-02Labeling · Supplement 101AP
1989-10-18Labeling · Supplement 100AP
1987-02-02Manufacturing (CMC) · Supplement 98AP
1987-02-02Manufacturing (CMC) · Supplement 99AP
1985-10-01Manufacturing (CMC) · Supplement 96AP
1985-07-08Manufacturing (CMC) · Supplement 95AP
1985-03-22Manufacturing (CMC) · Supplement 93AP
1984-08-22Manufacturing (CMC) · Supplement 91AP
1984-02-07Manufacturing (CMC) · Supplement 89AP
1983-07-12Manufacturing (CMC) · Supplement 87AP
1983-07-12Manufacturing (CMC) · Supplement 88AP
1983-05-23Manufacturing (CMC) · Supplement 85AP
1982-08-05Manufacturing (CMC) · Supplement 82AP
1972-11-03OriginalAP
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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