Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076137
Company: DR REDDYS LABS SA

Products on ANDA 076137

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076137

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/18/2002	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
12/28/2015	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/02/2015	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
01/28/2014	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/13/2011	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
08/31/2007	SUPPL-7	Labeling		Label is not available on this site.
03/23/2007	SUPPL-6	Labeling		Label is not available on this site.
11/05/2002	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
06/18/2002	SUPPL-1	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.