Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202893
Company: AUROLIFE PHARMA LLC

Products on ANDA 202893

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 202893

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/2013	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
03/08/2024	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/25/2022	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/04/2017	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/17/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202893

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