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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217123
Company: AUROBINDO PHARMA LTD

Products on ANDA 217123

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217123

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/09/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217123Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/08/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 217123

DEFLAZACORT

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	217741	SUN PHARM
DEFLAZACORT	DEFLAZACORT	6MG	TABLET;ORAL	Prescription	No	AB	216720	UPSHER SMITH LABS
EMFLAZA	DEFLAZACORT	6MG	TABLET;ORAL	Prescription	Yes	AB	208684	PTC THERAP
JAYTHARI	DEFLAZACORT	6MG	TABLET;ORAL	Prescription	No	AB	219254	ZYDUS LIFESCIENCES

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	217741	SUN PHARM
DEFLAZACORT	DEFLAZACORT	18MG	TABLET;ORAL	Prescription	No	AB	216720	UPSHER SMITH LABS
EMFLAZA	DEFLAZACORT	18MG	TABLET;ORAL	Prescription	Yes	AB	208684	PTC THERAP
JAYTHARI	DEFLAZACORT	18MG	TABLET;ORAL	Prescription	No	AB	219254	ZYDUS LIFESCIENCES

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	217741	SUN PHARM
DEFLAZACORT	DEFLAZACORT	30MG	TABLET;ORAL	Prescription	No	AB	216720	UPSHER SMITH LABS
EMFLAZA	DEFLAZACORT	30MG	TABLET;ORAL	Prescription	Yes	AB	208684	PTC THERAP
JAYTHARI	DEFLAZACORT	30MG	TABLET;ORAL	Prescription	No	AB	219254	ZYDUS LIFESCIENCES

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	217741	SUN PHARM
DEFLAZACORT	DEFLAZACORT	36MG	TABLET;ORAL	Prescription	No	AB	216720	UPSHER SMITH LABS
EMFLAZA	DEFLAZACORT	36MG	TABLET;ORAL	Prescription	Yes	AB	208684	PTC THERAP
JAYTHARI	DEFLAZACORT	36MG	TABLET;ORAL	Prescription	No	AB	219254	ZYDUS LIFESCIENCES

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