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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208684
Company: PTC THERAP

Products on NDA 208684

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMFLAZA	DEFLAZACORT	6MG	TABLET;ORAL	Prescription	AB	Yes	No
EMFLAZA	DEFLAZACORT	18MG	TABLET;ORAL	Prescription	AB	Yes	No
EMFLAZA	DEFLAZACORT	30MG	TABLET;ORAL	Prescription	AB	Yes	No
EMFLAZA	DEFLAZACORT	36MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208684

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/09/2017	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208684s000,208685s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208684Orig1s000,208685Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208684,208685Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2024	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208684s006,208685s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208684Orig1s006,208685Orig1s007ltr.pdf
06/29/2021	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208684s005,208685s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208684Orig1s005, 208685Orig1s005ltr.pdf
07/10/2020	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208684s004,208685s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208684Orig1s004,208685Orig1s004ltr.pdf
06/07/2019	SUPPL-3	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208684s003,208685s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208684Orig1s003,208685Orig1s003ltr.pdf

Labels for NDA 208684

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2024	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208684s006,208685s007lbl.pdf
06/29/2021	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208684s005,208685s005lbl.pdf
07/10/2020	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208684s004,208685s004lbl.pdf
06/07/2019	SUPPL-3	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208684s003,208685s003lbl.pdf
02/09/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208684s000,208685s000lbl.pdf

Therapeutic Equivalents for NDA 208684

EMFLAZA

TABLET;ORAL; 6MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFLAZACORT	DEFLAZACORT	6MG	TABLET;ORAL	Prescription	No	AB	217123	AUROBINDO PHARMA LTD
DEFLAZACORT	DEFLAZACORT	6MG	TABLET;ORAL	Prescription	No	AB	216720	UPSHER SMITH LABS
EMFLAZA	DEFLAZACORT	6MG	TABLET;ORAL	Prescription	Yes	AB	208684	PTC THERAP

TABLET;ORAL; 18MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFLAZACORT	DEFLAZACORT	18MG	TABLET;ORAL	Prescription	No	AB	217123	AUROBINDO PHARMA LTD
DEFLAZACORT	DEFLAZACORT	18MG	TABLET;ORAL	Prescription	No	AB	216720	UPSHER SMITH LABS
EMFLAZA	DEFLAZACORT	18MG	TABLET;ORAL	Prescription	Yes	AB	208684	PTC THERAP

TABLET;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFLAZACORT	DEFLAZACORT	30MG	TABLET;ORAL	Prescription	No	AB	217123	AUROBINDO PHARMA LTD
DEFLAZACORT	DEFLAZACORT	30MG	TABLET;ORAL	Prescription	No	AB	216720	UPSHER SMITH LABS
EMFLAZA	DEFLAZACORT	30MG	TABLET;ORAL	Prescription	Yes	AB	208684	PTC THERAP

TABLET;ORAL; 36MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFLAZACORT	DEFLAZACORT	36MG	TABLET;ORAL	Prescription	No	AB	217123	AUROBINDO PHARMA LTD
DEFLAZACORT	DEFLAZACORT	36MG	TABLET;ORAL	Prescription	No	AB	216720	UPSHER SMITH LABS
EMFLAZA	DEFLAZACORT	36MG	TABLET;ORAL	Prescription	Yes	AB	208684	PTC THERAP

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