APPLICATION
NDA006146
TYPE
NDA
ORIGINAL APPROVAL
1947-03-06
LATEST ACTION
1997-07-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BENADRYLDiscontinued
DIPHENHYDRAMINE HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION
BENADRYL · ReferenceDiscontinued
DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1997-07-01Manufacturing (CMC) · Supplement 13 · standardAP
1993-11-29Labeling · Supplement 12 · standardAP
1992-08-20Labeling · Supplement 11 · standardAP
1986-06-24Labeling · Supplement 9 · standardAP
1986-06-24Manufacturing (CMC) · Supplement 10 · standardAP
1984-08-10Labeling · Supplement 6 · standardAP
1947-03-06Type 3 - New Dosage Form · 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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