Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087717
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPYRIDAMOLE DIPYRIDAMOLE 75MG TABLET;ORAL Prescription AB 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
10/03/1990 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
08/18/2006 SUPPL-39 Labeling

Label is not available on this site.

10/05/2005 SUPPL-35 Labeling

Label is not available on this site.

03/07/2001 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/2001 SUPPL-32 Manufacturing (CMC)-Facility

Label is not available on this site.

12/21/1999 SUPPL-31 Manufacturing (CMC)-Facility

Label is not available on this site.

05/20/1999 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/30/1998 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/17/1996 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/13/1996 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/13/1992 SUPPL-22 Labeling

Label is not available on this site.

04/03/1992 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/30/1991 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/15/1990 SUPPL-17 Bioequivalence

Label is not available on this site.

10/07/1987 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/15/1987 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/15/1987 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/03/1990 SUPPL-12 Labeling

Label is not available on this site.

03/25/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

DIPYRIDAMOLE

TABLET;ORAL; 75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIPYRIDAMOLE DIPYRIDAMOLE 75MG TABLET;ORAL Prescription No AB 087717 BARR
DIPYRIDAMOLE DIPYRIDAMOLE 75MG TABLET;ORAL Prescription No AB 040782 IMPAX LABS
DIPYRIDAMOLE DIPYRIDAMOLE 75MG TABLET;ORAL Prescription No AB 040733 MURTY PHARMS
DIPYRIDAMOLE DIPYRIDAMOLE 75MG TABLET;ORAL Prescription No AB 040874 ZYDUS PHARMS USA INC
PERSANTINE DIPYRIDAMOLE 75MG TABLET;ORAL Prescription Yes AB 012836 BOEHRINGER INGELHEIM

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