Viewing data from:

ARALEN

NDA

CHLOROQUINE PHOSPHATE | N006002 | SANOFI AVENTIS US LLC

2 strengths0 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 Chain3 active DMFs1 inactive

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

IPCA LABORATORIES LTDCHLOROQUINE PHOSPHATE USP

DMF 92351991

NATCO PHARMA LTDCHLOROQUINE PHOSPHATE

DMF 330672019

COHANCE LIFESCIENCES LTDCHLOROQUINE PHOSPHATE USP

DMF 341302019

ICN HUNGARY CO LTDInactiveCHLOROQUINE PHOSPHATE

DMF 104721993

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

Approval Letters

5 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — EQ 40MG BASE/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982