Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076369
Company: PADAGIS ISRAEL

Products on ANDA 076369

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PERMETHRIN	PERMETHRIN	5%	CREAM;TOPICAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076369

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/21/2003	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 076369

PERMETHRIN

CREAM;TOPICAL; 5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PERMETHRIN	PERMETHRIN	5%	CREAM;TOPICAL	Prescription	No	AB	074806	ACTAVIS LABS
PERMETHRIN	PERMETHRIN	5%	CREAM;TOPICAL	Prescription	No	AB	209732	DR REDDYS LABS EU
PERMETHRIN	PERMETHRIN	5%	CREAM;TOPICAL	Prescription	No	AB	211303	ENCUBE ETHICALS
PERMETHRIN	PERMETHRIN	5%	CREAM;TOPICAL	Prescription	No	AB	076369	PADAGIS ISRAEL