Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040436
Company: SPECGX LLC

Products on ANDA 040436

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 040436

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/2002	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/040436Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2023	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/25/2022	SUPPL-22	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/04/2017	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/28/2016	SUPPL-14	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/17/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
01/29/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
04/29/2010	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
02/06/2008	SUPPL-5	Labeling		Label is not available on this site.
08/31/2007	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040436

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