Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076090
Company: PERRIGO NEW YORK

Products on ANDA 076090

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076090

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2001	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/076090.PDF

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/30/2010	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

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

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