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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074806
Company: ACTAVIS LABS

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/23/1998 ORIG-1 Approval Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074806ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/19/2002 SUPPL-14 Labeling

Label is not available on this site.
04/10/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
04/10/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
09/04/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
09/04/2001 SUPPL-10 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.
09/04/2001 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.
01/08/2001 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/29/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
01/08/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
11/30/2000 SUPPL-5 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.
09/21/2000 SUPPL-4 Labeling

Label is not available on this site.
09/21/2000 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/08/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
09/24/1999 SUPPL-1 Labeling

Label is not available on this site.

PERMETHRIN

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
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