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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202819
Company: SIGMAPHARM LABS LLC

Products on ANDA 202819

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM PHENYLBUTYRATE	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202819

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/2013	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 202819

SODIUM PHENYLBUTYRATE

POWDER;ORAL; 3GM/TEASPOONFUL
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPHENYL	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER;ORAL	Prescription	Yes	AB	020573	HORIZON THERAP US
SODIUM PHENYLBUTYRATE	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER;ORAL	Prescription	No	AB	203918	PAR PHARM
SODIUM PHENYLBUTYRATE	SODIUM PHENYLBUTYRATE	3GM/TEASPOONFUL	POWDER;ORAL	Prescription	No	AB	202819	SIGMAPHARM LABS LLC

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