APPLICATION
ANDA080817
TYPE
ANDA
ORIGINAL APPROVAL
1972-11-27
LATEST ACTION
2002-11-05
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DIPHENHYDRAMINE HYDROCHLORIDE · ReferencePrescription
DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
Approval history
2002-11-05Labeling · Supplement 41AP
1999-10-01Manufacturing (CMC) · Supplement 40AP
1999-06-08Manufacturing (CMC) · Supplement 35AP
1999-02-11Manufacturing (CMC) · Supplement 38AP
1998-12-01Manufacturing (CMC) · Supplement 37AP
1998-07-28Labeling · Supplement 39AP
1998-01-29Labeling · Supplement 36AP
1993-02-17Labeling · Supplement 34AP
1992-10-30Manufacturing (CMC) · Supplement 33AP
1992-07-23Manufacturing (CMC) · Supplement 31AP
1992-01-27Manufacturing (CMC) · Supplement 30AP
1990-11-05Labeling · Supplement 32AP
1990-06-07Labeling · Supplement 29AP
1988-11-23Labeling · Supplement 28AP
1986-11-03Manufacturing (CMC) · Supplement 26AP
1986-04-10Manufacturing (CMC) · Supplement 25AP
1983-02-08Manufacturing (CMC) · Supplement 23AP
1972-11-27OriginalAP
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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