APPLICATION
ANDA080614
TYPE
ANDA
ORIGINAL APPROVAL
1986-02-11
LATEST ACTION
1999-02-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DICYCLOMINE HYDROCHLORIDEDiscontinued
DICYCLOMINE HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION
Approval history
1999-02-19Manufacturing (CMC) · Supplement 43AP
1999-02-02Manufacturing (CMC) · Supplement 42AP
1998-03-25Labeling · Supplement 39AP
1996-08-28Manufacturing (CMC) · Supplement 37AP
1991-07-23Labeling · Supplement 36AP
1990-11-14Labeling · Supplement 35AP
1988-11-15Manufacturing (CMC) · Supplement 33AP
1988-07-14Labeling · Supplement 32AP
1986-06-16Manufacturing (CMC) · Supplement 30AP
1986-02-11OriginalAP
1985-01-11Manufacturing (CMC) · Supplement 29AP
1984-02-22Manufacturing (CMC) · Supplement 27AP
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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