Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019855
Company: AUROBINDO PHARMA USA

Products on NDA 019855

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019855

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/25/1989	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/12/2016	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/27/2001	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
03/23/2000	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
01/11/2001	SUPPL-5	Labeling		Label is not available on this site.
01/30/1995	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/14/1994	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
05/05/1993	SUPPL-1	Efficacy-New Dosing Regimen		Label is not available on this site.

Therapeutic Equivalents for NDA 019855

ELIMITE

CREAM;TOPICAL; 5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ELIMITE	PERMETHRIN	5%	CREAM;TOPICAL	Prescription	Yes	AB	019855	AUROBINDO PHARMA USA
PERMETHRIN	PERMETHRIN	5%	CREAM;TOPICAL	Prescription	No	AB	074806	ACTAVIS LABS
PERMETHRIN	PERMETHRIN	5%	CREAM;TOPICAL	Prescription	No	AB	211303	ENCUBE ETHICALS
PERMETHRIN	PERMETHRIN	5%	CREAM;TOPICAL	Prescription	No	AB	076369	PADAGIS ISRAEL