Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040782
Company: IMPAX LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPYRIDAMOLE DIPYRIDAMOLE 25MG TABLET;ORAL Prescription AB No No
DIPYRIDAMOLE DIPYRIDAMOLE 50MG TABLET;ORAL Prescription AB No No
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
07/18/2007 ORIG-1 Approval

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

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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