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NDA

LINDANE | N010718 | REED AND CARNRICK PHARMACEUTICALS DIV BLOCK DRUG CO INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Natural Resources Defence Council, et al - Citizen Petition FDA-2010-P-0312 · 11 docket documents The Natural Resources Defense Council and ten supporting organizations filed this citizen petition under 21 U.S.C. § 355(e) and 21 C.F.R. §§ 10.25(a), 10.30, and 10.33 requesting that the FDA Commissioner establish a regulation prohibiting lindane as a pharmaceutical treatment for head lice and scab	Other	2010-07-19	Denied	—

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

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pediatric Head Lice Study Product Comparison NCT02213055	Phase 2	Completed	Hackensack Meridian Health	97	2009-05 → 2014-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain0 active DMFs2 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

RHONE POULENC RORER PHARMACEUTICALS INCInactiveLINDANE

DMF 81671989

OLTA PHARMACEUTICALS CORPInactiveLINDANE, USP

DMF 222592009

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

Products (1)

#001 — 1%

0 patents0 exclusivities▴

SHAMPOO;TOPICAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.