APPLICATION
ANDA084767
TYPE
ANDA
ORIGINAL APPROVAL
1976-09-13
LATEST ACTION
1992-02-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DIMENHYDRINATEDiscontinued
DIMENHYDRINATE 50MG/ML · INJECTABLE · INJECTION
Approval history
1992-02-27Manufacturing (CMC) · Supplement 12AP
1987-11-06Manufacturing (CMC) · Supplement 11AP
1982-07-28Manufacturing (CMC) · Supplement 9AP
1976-09-13OriginalAP
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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