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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075014
Company: ACTAVIS MID ATLANTIC

Products on ANDA 075014

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 075014

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.

Labels for ANDA 075014

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

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

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