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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207997
Company: NOVARTIS

Products on NDA 207997

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RYDAPT	MIDOSTAURIN	25MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207997

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2017	ORIG-2	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207997Orig1Orig2s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207997Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207997Orig1Orig2s000TOC.cfm
04/28/2017	ORIG-1	Approval	Efficacy	PRIORITY; Orphan	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207997s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207997Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2023	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207997s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207997Orig1s010ltr.pdf
11/15/2021	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207997s008lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207997Orig1s008ltr.pdf
04/20/2021	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207997s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207997Orig1s007ltr.pdf
11/24/2020	SUPPL-6	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207997s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207997Orig1s006ltr.pdf
03/04/2020	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207997s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207997Orig1s004ltr.pdf
06/21/2018	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207997s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207997Orig1s002ltr.pdf

Labels for NDA 207997

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2023	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207997s010lbl.pdf
11/15/2021	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207997s008lbledt.pdf
04/20/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207997s007lbl.pdf
11/24/2020	SUPPL-6	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207997s006lbl.pdf
03/04/2020	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207997s004lbl.pdf
06/21/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207997s002lbl.pdf
04/28/2017	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207997Orig1Orig2s000lbl.pdf
04/28/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207997s000lbl.pdf

Therapeutic Equivalents for NDA 207997

RYDAPT

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIDOSTAURIN	MIDOSTAURIN	25MG	CAPSULE;ORAL	Prescription	No	AB	215921	DR REDDYS
MIDOSTAURIN	MIDOSTAURIN	25MG	CAPSULE;ORAL	Prescription	No	AB	216015	LUPIN
RYDAPT	MIDOSTAURIN	25MG	CAPSULE;ORAL	Prescription	Yes	AB	207997	NOVARTIS

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