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): 215185
Company: TASMAN PHARMA

Products on ANDA 215185

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215185

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215185

KETOCONAZOLE

CREAM;TOPICAL; 2%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KETOCONAZOLE	KETOCONAZOLE	2%	CREAM;TOPICAL	Prescription	No	AB	212443	ENCUBE
KETOCONAZOLE	KETOCONAZOLE	2%	CREAM;TOPICAL	Prescription	No	AB	076294	FOUGERA PHARMS
KETOCONAZOLE	KETOCONAZOLE	2%	CREAM;TOPICAL	Prescription	No	AB	215185	TASMAN PHARMA
KETOCONAZOLE	KETOCONAZOLE	2%	CREAM;TOPICAL	Prescription	No	AB	075581	TEVA
KETOZOLE	KETOCONAZOLE	2%	CREAM;TOPICAL	Prescription	No	AB	075638	TARO PHARMS

Top