Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211639
Company: AUROLIFE PHARMA LLC

Products on ANDA 211639

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211639

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/17/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/16/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
02/25/2022	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211639

AMPHETAMINE SULFATE

TABLET;ORAL; 5MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	213720	ALKEM LABS LTD
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	211139	AMNEAL PHARMS
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	211639	AUROLIFE PHARMA LLC
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	212919	BIONPHARMA
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	212582	CEROVENE INC
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	213980	EPIC PHARMA LLC
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	212619	GRANULES
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	211861	PRINSTON INC
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	213852	RHODES PHARMS
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	212901	SENORES PHARMS
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	213583	SPECGX LLC
EVEKEO	AMPHETAMINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AA	200166	AZURITY

TABLET;ORAL; 10MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	213720	ALKEM LABS LTD
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	211139	AMNEAL PHARMS
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	211639	AUROLIFE PHARMA LLC
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	212919	BIONPHARMA
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	212582	CEROVENE INC
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	213980	EPIC PHARMA LLC
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	212619	GRANULES
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	211861	PRINSTON INC
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	213852	RHODES PHARMS
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	212901	SENORES PHARMS
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	213583	SPECGX LLC
EVEKEO	AMPHETAMINE SULFATE	10MG	TABLET;ORAL	Prescription	No	AA	200166	AZURITY