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ANDA

DANTROLENE SODIUM | A078378 | USWM LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: DANTRIUM(TE code: AP)

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
Jul 27, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jul 24, 2007

No patent or exclusivity listings for this strength.