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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074939
Company: CHARTWELL INJECTABLE

Products on ANDA 074939

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIPYRIDAMOLE	DIPYRIDAMOLE	5MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074939

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/13/1998	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
04/03/2001	SUPPL-1	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.

Therapeutic Equivalents for ANDA 074939

DIPYRIDAMOLE

INJECTABLE;INJECTION; 5MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIPYRIDAMOLE	DIPYRIDAMOLE	5MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074939	CHARTWELL INJECTABLE
DIPYRIDAMOLE	DIPYRIDAMOLE	5MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074521	HIKMA

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