Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012836
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERSANTINE DIPYRIDAMOLE 25MG TABLET;ORAL Prescription AB Yes No
PERSANTINE DIPYRIDAMOLE 50MG TABLET;ORAL Prescription AB Yes No
PERSANTINE DIPYRIDAMOLE 75MG TABLET;ORAL Prescription AB Yes 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
12/06/1961 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/29/2015 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

05/08/2014 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

08/01/2005 SUPPL-57 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/012836s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/012836s057ltr.pdf
06/20/2002 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2002 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

08/05/2004 SUPPL-54 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12836s054ltr.pdf
05/24/2001 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

02/08/2000 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

07/03/1997 SUPPL-51 Labeling

Label is not available on this site.

05/18/1994 SUPPL-50 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/18/1994 SUPPL-49 Labeling

Label is not available on this site.

03/26/1991 SUPPL-47 Labeling

Label is not available on this site.

02/21/1995 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

11/08/1988 SUPPL-45 Labeling

Label is not available on this site.

08/30/1989 SUPPL-44 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/12/1988 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

02/24/1988 SUPPL-41 Labeling

Label is not available on this site.

02/06/1987 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1986 SUPPL-38 Labeling

Label is not available on this site.

10/08/1982 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

12/22/1986 SUPPL-14 Efficacy-New Indication

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/01/2005 SUPPL-57 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/012836s057lbl.pdf

PERSANTINE

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

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIPYRIDAMOLE DIPYRIDAMOLE 50MG TABLET;ORAL Prescription No AB 087716 BARR
DIPYRIDAMOLE DIPYRIDAMOLE 50MG TABLET;ORAL Prescription No AB 040782 IMPAX LABS
DIPYRIDAMOLE DIPYRIDAMOLE 50MG TABLET;ORAL Prescription No AB 040733 MURTY PHARMS
DIPYRIDAMOLE DIPYRIDAMOLE 50MG TABLET;ORAL Prescription No AB 040874 ZYDUS PHARMS USA INC
PERSANTINE DIPYRIDAMOLE 50MG TABLET;ORAL Prescription Yes AB 012836 BOEHRINGER INGELHEIM

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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