Viewing data from:

DANTROLENE SODIUM

ANDA

DANTROLENE SODIUM | A205239 | EUGIA PHARMA SPECIALITIES LTD

1 strength0 unique patents0 unique exclusivities

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

1 letter from Drugs@FDA

Date	Submission	Document
Feb 22, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Feb 18, 2016

No patent or exclusivity listings for this strength.