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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019918
Company: MEDTECH PRODUCTS

Products on NDA 019918

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019918

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.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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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