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): 218559
Company: ZYDUS LIFESCIENCES

Products on ANDA 218559

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 218559

Original Approvals or Tentative Approvals

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

Therapeutic Equivalents for ANDA 218559

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

Top