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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219129
Company: NOVITIUM PHARMA

Products on ANDA 219129

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KETOCONAZOLE	KETOCONAZOLE	200MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219129

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/03/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219129

KETOCONAZOLE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KETOCONAZOLE	KETOCONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	219129	NOVITIUM PHARMA
KETOCONAZOLE	KETOCONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	075912	SENORES PHARMS
KETOCONAZOLE	KETOCONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	210457	STRIDES PHARMA
KETOCONAZOLE	KETOCONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	075319	TARO

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