An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

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
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
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
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
EMFLAZA	DEFLAZACORT	36MG	TABLET;ORAL	Prescription	Yes	AB	208684	PTC THERAP

Top