Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084600
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 20MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/20/1975 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/01/1998 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

03/09/1998 SUPPL-46 Labeling

Label is not available on this site.

12/23/1994 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

01/11/1991 SUPPL-40 Labeling

Label is not available on this site.

05/01/1991 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

08/24/1990 SUPPL-37 Labeling

Label is not available on this site.

06/01/1989 SUPPL-36 Labeling

Label is not available on this site.

03/20/1987 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

07/25/1985 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

07/25/1985 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

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