Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086173
Company: FOSUN PHARMA
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
08/28/1981 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
11/28/2000 SUPPL-11 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

04/03/2000 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

04/06/1999 SUPPL-9 Labeling

Label is not available on this site.

07/26/1988 SUPPL-8 Bioequivalence

Label is not available on this site.

05/16/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/16/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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