APPLICATION
ANDA080615
TYPE
ANDA
ORIGINAL APPROVAL
1974-01-29
LATEST ACTION
1999-02-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DIMENHYDRINATE · ReferenceDiscontinued
DIMENHYDRINATE 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1999-02-19Manufacturing (CMC) · Supplement 171AP
1999-02-02Manufacturing (CMC) · Supplement 169AP
1998-11-02Manufacturing (CMC) · Supplement 170AP
1996-08-27Manufacturing (CMC) · Supplement 168AP
1991-01-11Labeling · Supplement 167AP
1989-09-27Manufacturing (CMC) · Supplement 166AP
1989-09-27Manufacturing (CMC) · Supplement 165AP
1989-03-31Manufacturing (CMC) · Supplement 164AP
1988-09-19Manufacturing (CMC) · Supplement 159AP
1988-08-03Manufacturing (CMC) · Supplement 162AP
1988-08-03Manufacturing (CMC) · Supplement 161AP
1986-05-28Manufacturing (CMC) · Supplement 157AP
1982-04-05Manufacturing (CMC) · Supplement 154AP
1974-01-29OriginalAP
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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