Viewing data from:

LOMOTIL

NDA

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE | N012699 | GD SEARLE LLC

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
Citizens Petition from Lachman Consultant Services, Inc. FDA-2005-P-0381 · 5 docket documents Lachman Consultant Services, Inc. filed this petition on April 25, 2005, requesting that the FDA declare Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP 5 mg/0.05 mg suitable for submission as an ANDA based on the reference listed drug Lomotil Tablets 2.5 mg/0.025 mg. The petition seeks	Other	2008-12-24	Denied	Lachman Consultant Services, Inc.

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
Indenoisoquinoline LMP744 in Adults With Relapsed Solid Tumors and Lymphomas NCT03030417	Phase 1	Completed	National Cancer Institute (NCI)	36	2017-02-27 → 2023-10-12

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 2, 2006	SUPPL -36	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.025MG/5ML;2.5MG/5ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.