Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087708
Company: WEST-WARD PHARMS INT
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/5ML;2.5MG/5ML SOLUTION;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/03/1982 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
05/05/2017 SUPPL-22 Labeling-Container/Carton Labels

Label is not available on this site.

07/31/2008 SUPPL-21 Labeling

Label is not available on this site.

11/16/2007 SUPPL-20 Labeling

Label is not available on this site.

03/28/2007 SUPPL-19 Labeling

Label is not available on this site.

12/28/2001 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/03/2001 SUPPL-15 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/03/2001 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/03/2001 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/03/2001 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/20/1998 SUPPL-11 Labeling

Label is not available on this site.

08/12/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/06/1994 SUPPL-7 Labeling

Label is not available on this site.

06/27/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/15/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/15/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/01/1989 SUPPL-3 Labeling

Label is not available on this site.

09/23/1988 SUPPL-1 Bioequivalence

Label is not available on this site.

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