APPLICATION
ANDA085223
TYPE
ANDA
ORIGINAL APPROVAL
1976-08-17
LATEST ACTION
2013-11-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DICYCLOMINE HYDROCHLORIDEPrescription
DICYCLOMINE HYDROCHLORIDE 20MG · TABLET · ORAL
Approval history
2013-11-27Labeling · Supplement 44 · standardAP
2013-08-13Labeling · Supplement 43 · standardAP
2012-12-31Labeling · Supplement 42 · standardAP
1998-03-25Labeling · Supplement 39AP
1997-07-16Manufacturing (CMC) · Supplement 38AP
1997-07-16Manufacturing (CMC) · Supplement 37AP
1996-01-19Manufacturing (CMC) · Supplement 36AP
1996-01-19Manufacturing (CMC) · Supplement 34AP
1996-01-19Manufacturing (CMC) · Supplement 35AP
1995-05-26Manufacturing (CMC) · Supplement 33AP
1994-07-11Manufacturing (CMC) · Supplement 32AP
1991-03-12Labeling · Supplement 31AP
1990-08-23Labeling · Supplement 26AP
1990-03-15Labeling · Supplement 25AP
1989-03-31Manufacturing (CMC) · Supplement 23AP
1989-03-31Manufacturing (CMC) · Supplement 22AP
1988-08-15Manufacturing (CMC) · Supplement 21AP
1986-07-30Manufacturing (CMC) · Supplement 19AP
1986-03-04Manufacturing (CMC) · Supplement 18AP
1982-12-06Manufacturing (CMC) · Supplement 11AP
1982-12-06Manufacturing (CMC) · Supplement 12AP
1982-05-13Manufacturing (CMC) · Supplement 10AP
1979-09-26Manufacturing (CMC) · Supplement 4AP
1976-08-17OriginalAP
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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