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PERMETHRIN

ANDA

PERMETHRIN | A074806 | ACTAVIS LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ELIMITE(TE code: AB)

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lachman Consultant Services, Inc. FDA-2019-P-3809 · 3 docket documents Lachman Consultant Services, Inc. filed this petition under section 505(j) of the FDC Act requesting that the FDA designate either Permethrin Cream 5% ANDA 074806 held by Actavis Laboratories, Inc. or Permethrin Cream 5% ANDA 076369 held by Perrigo Israel Pharmaceuticals, Ltd. as the new Reference S	505(q)	2019-08-13	Partially DeniedUnverified summary	Lachman Consultant Services, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$98.01

Highest Price

$98.01

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00472-0242-60PERMETHRIN 5% CREAM	$98.01	FSS	AvKare, LLC	06/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain4 active DMFs1 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

DR REDDYS LABORATORIES LTDPERMETHRIN BPC CIS:TRANS/25:75

DMF 117021995

SRIKEM LABORATORIES PVT LTDPERMETHRIN

DMF 280902014

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPERMETHRIN

DMF 302432016

WAVELENGTH ENTERPRISES LTDPERMETHRIN

DMF 311902016

FMC CORPInactivePERMETHRIN

DMF 121451996

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 5%

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Jan 23, 1998

No patent or exclusivity listings for this strength.