APPLICATION
ANDA080727
TYPE
ANDA
ORIGINAL APPROVAL
1972-09-27
LATEST ACTION
1999-10-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DIPHENHYDRAMINE HYDROCHLORIDEDiscontinued
DIPHENHYDRAMINE HYDROCHLORIDE 50MG · CAPSULE · ORAL
Approval history
1999-10-29Manufacturing (CMC) · Supplement 46AP
1991-05-31Manufacturing (CMC) · Supplement 43AP
1991-01-28Manufacturing (CMC) · Supplement 44AP
1990-06-29Manufacturing (CMC) · Supplement 42AP
1988-07-21Manufacturing (CMC) · Supplement 40AP
1988-07-21Manufacturing (CMC) · Supplement 39AP
1988-07-21Manufacturing (CMC) · Supplement 41AP
1985-09-11Manufacturing (CMC) · Supplement 36AP
1985-09-11Manufacturing (CMC) · Supplement 35AP
1982-08-04Manufacturing (CMC) · Supplement 31AP
1972-09-27OriginalAP
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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