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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203696
Company: ABBVIE ENDOCRINE

Medication Guide

Summary Review

Products on NDA 203696

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LUPANETA PACK	LEUPROLIDE ACETATE; NORETHINDRONE ACETATE	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET;INTRAMUSCULAR, ORAL	Discontinued	None	Yes	No
LUPANETA PACK	LEUPROLIDE ACETATE; NORETHINDRONE ACETATE	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET;INTRAMUSCULAR, ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203696

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2012	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Review Summary Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203696_lupaneta_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203696Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/31/2023	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203696s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203696Orig1s007ltr.pdf
08/09/2023	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203696s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203696Orig1s005,s006ltr.pdf
08/09/2023	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203696s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203696Orig1s005,s006ltr.pdf
04/29/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/20/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
10/30/2013	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203696s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020708Orig1s034,019943Orig1s034,020011Orig1s041,203696Orig1s001ltr.pdf

Labels for NDA 203696

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/09/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203696s005s006lbl.pdf
08/09/2023	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203696s005s006lbl.pdf
01/31/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203696s007lbl.pdf
10/30/2013	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203696s001lbl.pdf

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