Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211488
Company: ACCORD

Products on NDA 211488

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CAMCEVI KIT	LEUPROLIDE MESYLATE	EQ 42MG BASE	EMULSION;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211488

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/25/2021	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211488s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211488Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211488Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/13/2024	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211488s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211488Orig1s004ltr.pdf

Labels for NDA 211488

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/13/2024	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211488s004lbl.pdf
03/13/2024	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211488s004lbl.pdf
05/25/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211488s000lbl.pdf