Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216992
Company: UPSHER SMITH LABS

Products on ANDA 216992

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEFLAZACORT	DEFLAZACORT	22.75MG/ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216992

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/11/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/09/2026	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 216992

DEFLAZACORT

SUSPENSION;ORAL; 22.75MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFLAZACORT	DEFLAZACORT	22.75MG/ML	SUSPENSION;ORAL	Prescription	No	AB	220709	CARNEGIE
DEFLAZACORT	DEFLAZACORT	22.75MG/ML	SUSPENSION;ORAL	Prescription	No	AB	219930	SUN PHARM INDS INC
DEFLAZACORT	DEFLAZACORT	22.75MG/ML	SUSPENSION;ORAL	Prescription	No	AB	217813	TRIS PHARMA INC
DEFLAZACORT	DEFLAZACORT	22.75MG/ML	SUSPENSION;ORAL	Prescription	No	AB	216992	UPSHER SMITH LABS
DEFLAZACORT	DEFLAZACORT	22.75MG/ML	SUSPENSION;ORAL	Prescription	No	AB	220042	ZYDUS LIFESCIENCES
EMFLAZA	DEFLAZACORT	22.75MG/ML	SUSPENSION;ORAL	Prescription	Yes	AB	208685	PTC THERAP
PYQUVI	DEFLAZACORT	22.75MG/ML	SUSPENSION;ORAL	Prescription	No	AB	219417	AUCTA