Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203644
Company: TRIS PHARMA INC

Products on ANDA 203644

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203644

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/29/2013	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
10/13/2023	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/25/2022	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
01/04/2017	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/27/2016	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/17/2015	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 203644

DEXTROAMPHETAMINE SULFATE

SOLUTION;ORAL; 5MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	040776	PRASCO
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	203644	TRIS PHARMA INC