Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076419
Company: PADAGIS ISRAEL

Products on ANDA 076419

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076419

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/07/2004	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076419.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/31/2015	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
03/18/2013	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
02/04/2011	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
02/01/2008	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076419

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	076419	PADAGIS ISRAEL
KETOCONAZOLE	KETOCONAZOLE	2%	SHAMPOO;TOPICAL	Prescription	No	AB	076942	TOLMAR