Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075014
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERMETHRIN PERMETHRIN 1% LOTION;TOPICAL Over-the-counter None 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
03/28/2000 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75014_Permethrin_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075014_permethrin_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/08/2012 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

06/29/2005 SUPPL-11 Labeling

Label is not available on this site.

08/28/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/2001 SUPPL-7 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

08/28/2001 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

08/28/2001 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/2001 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/01/2001 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/28/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75014_Permethrin_Prntlbl.pdf

PERMETHRIN

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

LOTION;TOPICAL; 1%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NIX PERMETHRIN 1% LOTION;TOPICAL Over-the-counter Yes 019918 MEDTECH PRODUCTS
PERMETHRIN PERMETHRIN 1% LOTION;TOPICAL Over-the-counter No 075014 ACTAVIS MID ATLANTIC
PERMETHRIN PERMETHRIN 1% LOTION;TOPICAL Over-the-counter No 076090 PERRIGO NEW YORK

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