Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 083903
Company: LANNETT

Products on ANDA 083903

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083903

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/1975	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
10/13/2023	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
02/25/2022	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
01/04/2017	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
04/17/2015	SUPPL-26	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/08/2003	SUPPL-24	Labeling		Label is not available on this site.
09/19/1991	SUPPL-19	Labeling		Label is not available on this site.
12/17/1990	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
09/19/1991	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
09/19/1991	SUPPL-16	Labeling		Label is not available on this site.
06/05/1987	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
01/17/1986	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
01/03/1986	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/13/1985	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.