Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040776
Company: PRASCO

• Medication Guide

Products on ANDA 040776

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040776

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/2008	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2008/040776Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2023	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
02/25/2022	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
01/04/2017	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/27/2016	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/17/2015	SUPPL-2	Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040776

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