Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088999
Company: GLENMARK GENERICS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPYRIDAMOLE DIPYRIDAMOLE 25MG 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
02/05/1991 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
05/11/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/11/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/23/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/23/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/28/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/07/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/30/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/13/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/25/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/25/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/01/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/03/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/05/1991 SUPPL-1 Labeling

Label is not available on this site.

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