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QUALAQUIN

NDA

QUININE SULFATE | N021799 | SUN PHARMACEUTICAL INDUSTRIES 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

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety, Tolerability and Symptomatic Efficacy of the ROCK-Inhibitor Fasudil in Patients With Parkinson's Disease NCT05931575	Phase 2	Active	Technical University of Munich	75	2023-09-11 → 2026-09-30

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

API Supply Chain1 active DMF4 inactive

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

SHIVA INTERNATIONALQUININE SULFATE USP

DMF 240632010

DSM MINERA BVInactiveQUININE SULFATE USP XIX/ NF XII

DMF 33981978

BOEHRINGER MANNHEIM GMBHInactiveQUININE SULFATE

DMF 94621991

PT SINKONA INDONESIA LESTARIInactiveQUININE SULFATE USP

DMF 199052006

PT KIMIA FARMA PERSERO TBKInactiveQUININE SULFATE

DMF 209512007

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

Approval Letters

13 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 324MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Aug 12, 2005

No patent or exclusivity listings for this strength.