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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021288
Company: VERITY

Other Important Information from FDA

Products on NDA 021288

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRELSTAR	TRIPTORELIN PAMOATE	EQ 11.25MG BASE/VIAL	INJECTABLE;INTRAMUSCULAR	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021288

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2001	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21288lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21288ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-288_Trelstar.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/12/2024	SUPPL-44	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020715s049,021288s044,022437s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020715Orig1s049; 021288Orig1s044; 022437Orig1s024ltr.pdf
11/17/2023	SUPPL-42	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020715s047,021288s042,022437s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020715Orig1s047; 021288Orig1s042; 022437Orig1s022ltr.pdf
03/03/2023	SUPPL-40	Labeling-Container/Carton Labels, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020715s045,021288s040,022437s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020715Orig1s045;021288Orig1s040;022437Orig1s020ltr.pdf
12/14/2018	SUPPL-35	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020715s040,021288s035,022427s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020715Orig1s040,%20021288Orig1s035,%20022437Orig1s015ltr.pdf
07/15/2014	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
07/11/2014	SUPPL-28	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020715s032,021288s028,022437s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020715Orig1s032,021288Orig1s028,022437Orig1s008ltr.pdf
03/12/2013	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020715s030,021288s027,022437s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020715Orig1s030,021288Orig1s027,022437Orig1s007ltr.pdf
04/25/2013	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
05/19/2011	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020715s025,021288s022,022437s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020715s025,021288s022,022437s003ltr.pdf
01/14/2011	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020715s024,021288s021,022437s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020715s024,021288s021,022437s002ltr.pdf
03/17/2010	SUPPL-15	Labeling		Label is not available on this site.
04/14/2008	SUPPL-13	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020715s016, 021288s013ltr.pdf
02/16/2007	SUPPL-9	Labeling-Container/Carton Labels		Label is not available on this site.
10/20/2005	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021288s002,020715s006ltr.pdf

Labels for NDA 021288

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/12/2024	SUPPL-44	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020715s049,021288s044,022437s024lbl.pdf
11/17/2023	SUPPL-42	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020715s047,021288s042,022437s022lbl.pdf
03/03/2023	SUPPL-40	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020715s045,021288s040,022437s020lbl.pdf
03/03/2023	SUPPL-40	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020715s045,021288s040,022437s020lbl.pdf
12/14/2018	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020715s040,021288s035,022427s015lbl.pdf
07/11/2014	SUPPL-28	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020715s032,021288s028,022437s008lbl.pdf
03/12/2013	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020715s030,021288s027,022437s007lbl.pdf
05/19/2011	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020715s025,021288s022,022437s003lbl.pdf
01/14/2011	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020715s024,021288s021,022437s002lbl.pdf
06/29/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21288lbl.pdf

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