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DANTRIUM

NDA

DANTROLENE SODIUM | N018264 | PH HEALTH LTD

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 Chain6 active DMFs1 inactive

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

JINAN JINDA PHARMACEUTICAL CHEMISTRY CO LTDDANTROLENE SODIUM NON-STERILE BULK DRUG SUBSTANCE

DMF 151672000

SCINOPHARM TAIWAN LTDDANTROLENE SODIUM USP

DMF 161182002

HAS HEALTHCARE ADVANCED SYNTHESIS SADANTROLENE SODIUM DRUG SUBSTANCE

DMF 194982006

VERANOVA LPDANTROLENE SODIUM (DTE)

DMF 207792007

BIOPHORE INDIA PHARMACEUTICALS PVT LTDDANTROLENE SODIUM

DMF 338452019

GLAND PHARMA LTDDANTROLENE SODIUM

DMF 393052024

FDC LTDInactiveDANTROLENE SODIUM

DMF 174462004

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 3, 2024	SUPPL -42	View Letter (PDF)
Oct 27, 2008	SUPPL -25	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG/VIAL

RLDAP

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.