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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203619
Company: HIKMA

Products on ANDA 203619

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENTOBARBITAL SODIUM	PENTOBARBITAL SODIUM	50MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203619

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/13/2017	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 203619

PENTOBARBITAL SODIUM

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NEMBUTAL SODIUM	PENTOBARBITAL SODIUM	50MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	083246	RISING
PENTOBARBITAL SODIUM	PENTOBARBITAL SODIUM	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	206677	BPI LABS
PENTOBARBITAL SODIUM	PENTOBARBITAL SODIUM	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	203619	HIKMA
PENTOBARBITAL SODIUM	PENTOBARBITAL SODIUM	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	206404	SAGENT PHARMS INC

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