APPLICATION
NDA009486
TYPE
NDA
ORIGINAL APPROVAL
1957-12-30
LATEST ACTION
2003-10-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BENADRYL PRESERVATIVE FREE · ReferenceDiscontinued
DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2001-12-14Manufacturing (CMC) · Supplement 27 · standardAP
2000-03-30Manufacturing (CMC) · Supplement 26 · standardAP
1997-11-18Labeling · Supplement 22 · standardAP
1997-07-01Manufacturing (CMC) · Supplement 24 · standardAP
1997-06-06Manufacturing (CMC) · Supplement 23 · standardAP
1997-04-04Manufacturing (CMC) · Supplement 20 · standardAP
1997-03-31Labeling · Supplement 21 · standardAP
1996-05-13Labeling · Supplement 19 · standardAP
1992-08-20Labeling · Supplement 18 · standardAP
1986-07-16Labeling · Supplement 15 · standardAP
1986-07-16Manufacturing (CMC) · Supplement 17 · standardAP
1957-12-30Type 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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