Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203548
Company: AVANTHI INC

Products on ANDA 203548

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	AA	No	No
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203548

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/23/2015	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
03/08/2024	SUPPL-9	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.
02/01/2017	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203548

DEXTROAMPHETAMINE SULFATE

TABLET;ORAL; 5MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	202893	AUROLIFE PHARMA LLC
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	203548	AVANTHI INC
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	090533	AZURITY
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	040361	BARR
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	204330	NOVEL LABS INC
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	210059	NUVO PHARM
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	040436	SPECGX LLC
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	212160	WINDER LABS LLC

TABLET;ORAL; 10MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	202893	AUROLIFE PHARMA LLC
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	203548	AVANTHI INC
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	090533	AZURITY
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	040361	BARR
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	204330	NOVEL LABS INC
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	210059	NUVO PHARM
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	040436	SPECGX LLC
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	212160	WINDER LABS LLC