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New Drug Application (NDA): 011522
Company: TEVA WOMENS

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• Other Important Information from FDA

Products on NDA 11522

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADDERALL 10	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
ADDERALL 12.5	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
ADDERALL 15	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
ADDERALL 20	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
ADDERALL 30	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	7.5MG;7.5MG;7.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
ADDERALL 5	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
ADDERALL 7.5	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	1.875MG;1.875MG;1.875MG;1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Labels for NDA 011522

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2023	SUPPL-45	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011522s045lbl.pdf
02/25/2022	SUPPL-44	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf
01/04/2017	SUPPL-43	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011522s043lbl.pdf
10/01/2015	SUPPL-42	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011522s042lbl.pdf
04/17/2015	SUPPL-41	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011522s041lbl.pdf
06/07/2007	SUPPL-40	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011522s040lbl.pdf
07/26/2006	SUPPL-37	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf
07/26/2006	SUPPL-34	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf
08/02/2005	SUPPL-33	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/011522s032,033lbl.pdf
08/02/2005	SUPPL-32	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/011522s032,033lbl.pdf