Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084505
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG CAPSULE;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
06/23/1975 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-60 Manufacturing (CMC)

Label is not available on this site.

03/09/1998 SUPPL-59 Labeling

Label is not available on this site.

12/23/1994 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

12/18/1990 SUPPL-53 Labeling

Label is not available on this site.

10/31/1990 SUPPL-51 Labeling

Label is not available on this site.

06/08/1989 SUPPL-49 Labeling

Label is not available on this site.

03/20/1987 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

05/15/1986 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

05/15/1986 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

05/15/1986 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

05/15/1986 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

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