Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087184
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPYRIDAMOLE DIPYRIDAMOLE 25MG 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
09/29/1980 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-56 Labeling

Label is not available on this site.

10/05/2005 SUPPL-52 Labeling

Label is not available on this site.

07/27/2001 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/2001 SUPPL-49 Manufacturing (CMC)-Facility

Label is not available on this site.

12/21/1999 SUPPL-48 Manufacturing (CMC)-Facility

Label is not available on this site.

05/20/1999 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

07/15/1998 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

04/11/1997 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

08/13/1996 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

02/16/1994 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

08/13/1992 SUPPL-39 Labeling

Label is not available on this site.

04/03/1992 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

06/15/1990 SUPPL-35 Bioequivalence

Label is not available on this site.

09/24/1991 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

09/24/1991 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/24/1991 SUPPL-30 Labeling

Label is not available on this site.

09/24/1991 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

01/07/1988 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.

09/28/1987 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/03/1990 SUPPL-23 Labeling

Label is not available on this site.

04/06/1987 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

11/27/1984 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/24/1991 SUPPL-13 Labeling

Label is not available on this site.

DIPYRIDAMOLE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIPYRIDAMOLE DIPYRIDAMOLE 25MG TABLET;ORAL Prescription No AB 087184 BARR
DIPYRIDAMOLE DIPYRIDAMOLE 25MG TABLET;ORAL Prescription No AB 040782 IMPAX LABS
DIPYRIDAMOLE DIPYRIDAMOLE 25MG TABLET;ORAL Prescription No AB 040733 MURTY PHARMS
DIPYRIDAMOLE DIPYRIDAMOLE 25MG TABLET;ORAL Prescription No AB 040874 ZYDUS PHARMS USA INC
PERSANTINE DIPYRIDAMOLE 25MG TABLET;ORAL Prescription Yes AB 012836 BOEHRINGER INGELHEIM

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