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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208197
Company: HIKMA

Products on ANDA 208197

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DROPERIDOL	DROPERIDOL	2.5MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208197

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 208197

DROPERIDOL

INJECTABLE;INJECTION; 2.5MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DROPERIDOL	DROPERIDOL	2.5MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	072123	AM REGENT
DROPERIDOL	DROPERIDOL	2.5MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	208197	HIKMA

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