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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021731
Company: TOLMAR

Other Important Information from FDA

Products on NDA 021731

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELIGARD KIT	LEUPROLIDE ACETATE	45MG	POWDER;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021731

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021731s000_EligardTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/23/2024	SUPPL-51	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021343s051,021379s053,021488s048,021731s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021343Orig1s051, 021379Orig1s053, 021488Orig1s048, 021731Orig1s051ltr.pdf
07/20/2023	SUPPL-47	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021343s047s048,021379s049s050,021488s044s045,021731s044s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021343Orig1s047,s048;021379Orig1s049,s050;021488Orig1s044,s045;021731Orig1s044,s047ltr.pdf
07/20/2023	SUPPL-44	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021343s047s048,021379s049s050,021488s044s045,021731s044s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021343Orig1s047,s048;021379Orig1s049,s050;021488Orig1s044,s045;021731Orig1s044,s047ltr.pdf
11/25/2022	SUPPL-43			Label is not available on this site.
02/15/2019	SUPPL-37	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021343s039,021379s041,021488s036,021731s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021343Orig1s039,021731Orig1s037,021488Orig1s036,021379Orig1s041ltr.pdf
02/29/2016	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021343Orig1s033,021379Orig1s033,021488Orig1s030,021731Orig1s029ltr.pdf
10/10/2014	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021343s030,021379s030,021488s027,021731s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021343Orig1s030,021379Orig1s030,021488Orig1s027,021731Orig1s027ltr.pdf
07/18/2014	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
02/27/2013	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021343s027,021379s025,021488s025,021731s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021343Orig1s027,021379Orig1s025,021488Orig1s025,021731Orig1s023ltr.pdf
04/03/2013	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
04/08/2011	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s020,021379s016,021488s017,021731s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s020,021379s016,021488s017,021731s013ltr.pdf
01/14/2011	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s019,021379s015,021488s016,021731s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s019,021379s015,021488s016,021731s012ltr.pdf
10/05/2010	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021343s018,021379s014,021488s015,021731s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021343s018,021379s014,021488s015,021731s010ltr.pdf
11/08/2007	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021731s005,021488s010,021379s010,021343s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021343s015, 021488s010, 021379s010, 021731s005ltr.pdf
09/29/2006	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021731s004LTR.pdf

Labels for NDA 021731

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/23/2024	SUPPL-51	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021343s051,021379s053,021488s048,021731s051lbl.pdf
07/20/2023	SUPPL-47	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021343s047s048,021379s049s050,021488s044s045,021731s044s047lbl.pdf
07/20/2023	SUPPL-44	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021343s047s048,021379s049s050,021488s044s045,021731s044s047lbl.pdf
02/15/2019	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021343s039,021379s041,021488s036,021731s037lbl.pdf
02/29/2016	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf
10/10/2014	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021343s030,021379s030,021488s027,021731s027lbl.pdf
02/27/2013	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021343s027,021379s025,021488s025,021731s023lbl.pdf
04/08/2011	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s020,021379s016,021488s017,021731s013lbl.pdf
01/14/2011	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s019,021379s015,021488s016,021731s012lbl.pdf
10/05/2010	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021343s018,021379s014,021488s015,021731s010lbl.pdf
11/08/2007	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021731s005,021488s010,021379s010,021343s015lbl.pdf

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