Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218498
Company: NOVITIUM PHARMA

Products on ANDA 218498

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KETOCONAZOLE	KETOCONAZOLE	2%	SHAMPOO;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218498

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/16/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218498

KETOCONAZOLE

SHAMPOO;TOPICAL; 2%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KETOCONAZOLE	KETOCONAZOLE	2%	SHAMPOO;TOPICAL	Prescription	No	AB	076942	COSETTE PHARMS NC
KETOCONAZOLE	KETOCONAZOLE	2%	SHAMPOO;TOPICAL	Prescription	No	AB	218498	NOVITIUM PHARMA
KETOCONAZOLE	KETOCONAZOLE	2%	SHAMPOO;TOPICAL	Prescription	No	AB	076419	PADAGIS ISRAEL
KETOCONAZOLE	KETOCONAZOLE	2%	SHAMPOO;TOPICAL	Prescription	No	AB	218559	ZYDUS LIFESCIENCES