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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022561
Company: EMD SERONO INC

Medication Guide

Products on NDA 022561

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MAVENCLAD	CLADRIBINE	10MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022561

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/29/2019	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022561s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022561Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/022561Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/10/2024	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022561s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022561Orig1s011ltr.pdf
02/07/2024	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022561Orig1s009Corrected_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022561Orig1s009Corrected_ltr.pdf
12/06/2023	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022561s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022561Orig1s007ltr.pdf
09/19/2022	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022561s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022561Orig1s006ltr.pdf

Labels for NDA 022561

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/10/2024	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022561s011lbl.pdf
02/07/2024	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022561Orig1s009Corrected_lbl.pdf
12/06/2023	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022561s007lbl.pdf
12/06/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022561s007lbl.pdf
09/19/2022	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022561s006lbl.pdf
03/29/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022561s000lbl.pdf

Therapeutic Equivalents for NDA 022561

MAVENCLAD

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLADRIBINE	CLADRIBINE	10MG	TABLET;ORAL	Prescription	No	AB	218425	APOTEX
MAVENCLAD	CLADRIBINE	10MG	TABLET;ORAL	Prescription	Yes	AB	022561	EMD SERONO INC

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