Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074806
Company: ACTAVIS LABS

Products on ANDA 074806

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PERMETHRIN	PERMETHRIN	5%	CREAM;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074806

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/23/1998	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074806ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2002	SUPPL-14	Labeling		Label is not available on this site.
04/10/2002	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
04/10/2002	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
09/04/2001	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
09/04/2001	SUPPL-10	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
09/04/2001	SUPPL-9	Manufacturing (CMC)-Facility		Label is not available on this site.
01/08/2001	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/29/2000	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
01/08/2001	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
11/30/2000	SUPPL-5	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
09/21/2000	SUPPL-4	Labeling		Label is not available on this site.
09/21/2000	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/08/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/24/1999	SUPPL-1	Labeling		Label is not available on this site.