Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087160
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPYRIDAMOLE DIPYRIDAMOLE 50MG 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
06/07/1996 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
02/23/1998 SUPPL-40 Labeling

Label is not available on this site.

08/25/1997 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

08/25/1997 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

01/31/1997 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

04/07/1997 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

04/07/1997 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

05/24/1996 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

05/24/1996 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/07/1996 SUPPL-32 Labeling

Label is not available on this site.

07/13/1989 SUPPL-31 Bioequivalence

Label is not available on this site.

09/04/1987 SUPPL-30 Labeling

Label is not available on this site.

09/28/1987 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

09/28/1987 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/28/1987 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/28/1987 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/19/1989 SUPPL-25 Bioequivalence

Label is not available on this site.

06/30/1987 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/17/1986 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/30/1987 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

09/18/1986 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/14/1985 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/14/1985 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/21/1985 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/21/1985 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/21/1985 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/25/1983 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/25/1983 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/25/1983 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/25/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/12/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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