APPLICATION
ANDA084505
TYPE
ANDA
ORIGINAL APPROVAL
1975-06-23
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DICYCLOMINE HYDROCHLORIDEDiscontinued
DICYCLOMINE HYDROCHLORIDE 10MG · CAPSULE · ORAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 60AP
1998-03-09Labeling · Supplement 59AP
1994-12-23Manufacturing (CMC) · Supplement 58AP
1994-10-11Manufacturing (CMC) · Supplement 57AP
1992-04-03Manufacturing (CMC) · Supplement 56AP
1992-04-03Manufacturing (CMC) · Supplement 54AP
1990-12-18Labeling · Supplement 53AP
1990-10-31Labeling · Supplement 51AP
1989-06-08Labeling · Supplement 49AP
1987-03-20Manufacturing (CMC) · Supplement 47AP
1986-05-15Manufacturing (CMC) · Supplement 45AP
1986-05-15Manufacturing (CMC) · Supplement 43AP
1986-05-15Manufacturing (CMC) · Supplement 44AP
1986-05-15Manufacturing (CMC) · Supplement 42AP
1975-06-23OriginalAP
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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