Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074521
Company: HIKMA

Products on ANDA 074521

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074521

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/18/1996	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
01/11/2001	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
04/15/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/05/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/05/1997	SUPPL-4	Labeling		Label is not available on this site.
09/05/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/29/1997	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/29/1997	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074521

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