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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205054
Company: INVAGEN PHARMS

Products on NDA 205054

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	LEUPROLIDE ACETATE	22.5MG/VIAL	FOR SUSPENSION;INTRAMUSCULAR	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205054

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/28/2018	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205054s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205054Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/205054Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2023	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205054s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205054Orig1s005ltr.pdf
02/28/2023	SUPPL-4	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205054s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205054Orig1s004ltr.pdf

Labels for NDA 205054

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2023	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205054s005lbl.pdf
11/30/2023	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205054s005lbl.pdf
02/28/2023	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205054s004lbl.pdf
08/28/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205054s000lbl.pdf

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