Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017078
Company: IMPAX LABS INC

• Medication Guide

• Other Important Information from FDA

Products on NDA 17078

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

Labels for NDA 017078

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2025	SUPPL-59	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017078s059lbl.pdf
10/13/2023	SUPPL-55	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017078s055lbl.pdf
10/13/2023	SUPPL-55	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017078s055lbl.pdf
02/25/2022	SUPPL-54	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017078s054lbl.pdf
01/15/2019	SUPPL-52	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017078s052lbl.pdf
05/19/2017	SUPPL-50	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017078s050lbl.pdf
01/04/2017	SUPPL-49	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017078s049lbl.pdf
04/17/2015	SUPPL-48	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017078s048lbl.pdf
12/06/2013	SUPPL-47	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s047lbl.pdf
06/11/2013	SUPPL-46	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s046lbl.pdf
05/23/2008	SUPPL-44	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017078s044lbl.pdf
05/01/2007	SUPPL-42	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017078s042lbl.pdf
08/10/2006	SUPPL-40	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017078s040lbl.pdf