Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019918
Company: MEDTECH PRODUCTS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIX PERMETHRIN 1% LOTION;TOPICAL Over-the-counter None 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
05/02/1990 ORIG-1 Approval Type 8 - Partial Rx to OTC Switch 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
07/13/2000 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/17/2002 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19918s9ltr.pdf
04/14/1994 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1993 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1996 SUPPL-4 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019918ap.pdf
02/04/1992 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

NIX

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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