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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040874
Company: ZYDUS PHARMS USA INC

Products on ANDA 040874

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040874

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/28/2008	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
01/27/2021	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
01/27/2021	SUPPL-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040874

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	040542	OXFORD PHARMS
DIPYRIDAMOLE	DIPYRIDAMOLE	25MG	TABLET;ORAL	Prescription	No	AB	040733	RISING
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	040542	OXFORD PHARMS
DIPYRIDAMOLE	DIPYRIDAMOLE	50MG	TABLET;ORAL	Prescription	No	AB	040733	RISING
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	040542	OXFORD PHARMS
DIPYRIDAMOLE	DIPYRIDAMOLE	75MG	TABLET;ORAL	Prescription	No	AB	040733	RISING
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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