Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019855
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ELIMITE PERMETHRIN 5% CREAM;TOPICAL Prescription AB Yes Yes
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.

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 MYLAN
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 PERRIGO ISRAEL

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English