APPLICATION
NDA005845
TYPE
NDA
ORIGINAL APPROVAL
1946-03-04
LATEST ACTION
1987-01-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE, ELIXIR
MARKETING STATUS
Discontinued
Products
BENADRYLDiscontinued
DIPHENHYDRAMINE HYDROCHLORIDE 25MG · CAPSULE · ORAL
BENADRYLDiscontinued
DIPHENHYDRAMINE HYDROCHLORIDE 50MG · CAPSULE · ORAL
BENADRYLDiscontinued
DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML · ELIXIR · ORAL
Approval history
1987-01-14Manufacturing (CMC) · Supplement 44 · standardAP
1986-05-19Labeling · Supplement 38 · standardAP
1986-05-19Labeling · Supplement 42 · standardAP
1986-05-19Manufacturing (CMC) · Supplement 37 · standardAP
1986-05-19Labeling · Supplement 43 · standardAP
1985-08-07Manufacturing (CMC) · Supplement 39 · standardAP
1985-08-02Labeling · Supplement 40 · standardAP
1985-08-02Labeling · Supplement 41 · standardAP
1984-08-30Efficacy · Supplement 31 · standardAP
1984-08-30Manufacturing (CMC) · Supplement 33 · standardAP
1946-03-04Type 1 - New Molecular Entity · Original · standardAP
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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