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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083246
Company: RISING

Products on ANDA 083246

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEMBUTAL SODIUM	PENTOBARBITAL SODIUM	50MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083246

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/19/1973	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
04/27/2017	SUPPL-37	Labeling-Package Insert		Label is not available on this site.
05/12/2007	SUPPL-25	Labeling		Label is not available on this site.
09/25/2003	SUPPL-23	Labeling		Label is not available on this site.
05/10/2002	SUPPL-22	Manufacturing (CMC)-Facility		Label is not available on this site.
05/10/2002	SUPPL-21	Manufacturing (CMC)-Facility		Label is not available on this site.
12/29/1992	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
04/09/1986	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
06/17/1985	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 083246

NEMBUTAL 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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