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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205374
Company: DR REDDYS

Products on ANDA 205374

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	AB	No	No
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205374

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/22/2020	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
08/09/2023	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205374

FEBUXOSTAT

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	205421	ALEMBIC
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	212924	ALKEM LABS LTD
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	210741	AUROBINDO PHARMA LTD
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	205374	DR REDDYS
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	205414	HIKMA
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	210292	INDOCO
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	207293	MACLEODS PHARMS LTD
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	210461	MSN
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	206266	PRINSTON INC
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	205467	SUN PHARM
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	213069	SUNSHINE
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	205443	ZYDUS LIFESCIENCES
ULORIC	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	Yes	AB	021856	TAKEDA PHARMS USA

TABLET;ORAL; 80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	205421	ALEMBIC
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	212924	ALKEM LABS LTD
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	210741	AUROBINDO PHARMA LTD
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	205374	DR REDDYS
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	205414	HIKMA
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	210292	INDOCO
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	207293	MACLEODS PHARMS LTD
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	210461	MSN
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	206266	PRINSTON INC
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	205467	SUN PHARM
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	213069	SUNSHINE
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	205443	ZYDUS LIFESCIENCES
ULORIC	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	Yes	AB	021856	TAKEDA PHARMS USA

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