Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085506
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 0.025MG;2.5MG 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
06/03/1977 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-65 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

09/21/1993 SUPPL-63 Labeling

Label is not available on this site.

04/03/1992 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

02/15/1991 SUPPL-59 Labeling

Label is not available on this site.

04/10/1987 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

04/07/1983 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

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