APPLICATION
ANDA085082
TYPE
ANDA
ORIGINAL APPROVAL
1976-07-28
LATEST ACTION
2013-11-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DICYCLOMINE HYDROCHLORIDEPrescription
DICYCLOMINE HYDROCHLORIDE 10MG · CAPSULE · ORAL
Approval history
2013-11-27Labeling · Supplement 38 · standardAP
2013-08-13Labeling · Supplement 37 · standardAP
2012-12-31Labeling · Supplement 36 · standardAP
1997-07-23Manufacturing (CMC) · Supplement 33AP
1997-07-23Manufacturing (CMC) · Supplement 34AP
1997-07-23Manufacturing (CMC) · Supplement 32AP
1991-03-12Labeling · Supplement 31AP
1990-08-23Labeling · Supplement 30AP
1990-03-15Labeling · Supplement 29AP
1989-02-02Manufacturing (CMC) · Supplement 27AP
1989-02-02Manufacturing (CMC) · Supplement 28AP
1988-08-15Manufacturing (CMC) · Supplement 25AP
1988-01-22Manufacturing (CMC) · Supplement 23AP
1988-01-22Manufacturing (CMC) · Supplement 24AP
1986-05-20Manufacturing (CMC) · Supplement 21AP
1986-03-04Manufacturing (CMC) · Supplement 20AP
1983-06-21Manufacturing (CMC) · Supplement 15AP
1983-04-25Manufacturing (CMC) · Supplement 13AP
1983-04-25Manufacturing (CMC) · Supplement 14AP
1983-03-10Manufacturing (CMC) · Supplement 12AP
1983-03-10Manufacturing (CMC) · Supplement 11AP
1982-02-10Manufacturing (CMC) · Supplement 10AP
1976-07-28OriginalAP
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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