Viewing data from:

VANIQA

NDA

EFLORNITHINE HYDROCHLORIDE | N021145 | ABBVIE 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs

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

SCINOPHARM TAIWAN LTDEFLORNITHINE HYDROCHLORIDE

DMF 185092005

RUSAN PHARMA LTDEFLORNITHINE HYDROCHLORIDE MONOHYDRATE

DMF 317802017

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 27, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 13.9%

RLD

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Jul 27, 2000

No patent or exclusivity listings for this strength.