Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076353
Company: SPECGX LLC

Products on ANDA 076353

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076353

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/06/2003	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
10/25/2016	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
08/24/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
03/02/2015	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/02/2015	SUPPL-7	Labeling-Container/Carton Labels		Label is not available on this site.
09/30/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
01/16/2008	SUPPL-5	Labeling		Label is not available on this site.
08/31/2007	SUPPL-4	Labeling		Label is not available on this site.
03/23/2007	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076353

DEXTROAMPHETAMINE SULFATE

CAPSULE, EXTENDED RELEASE;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXEDRINE	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	017078	IMPAX LABS INC
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	203901	ACTAVIS ELIZABETH
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	076353	SPECGX LLC
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	205673	STRIDES PHARMA

CAPSULE, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXEDRINE	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	017078	IMPAX LABS INC
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	203901	ACTAVIS ELIZABETH
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	076353	SPECGX LLC
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	205673	STRIDES PHARMA

CAPSULE, EXTENDED RELEASE;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXEDRINE	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	017078	IMPAX LABS INC
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	203901	ACTAVIS ELIZABETH
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	076353	SPECGX LLC
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	205673	STRIDES PHARMA