Viewing data from:

DANTROLENE SODIUM

ANDA

DANTROLENE SODIUM | A076856 | IMPAX LABORATORIES INC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: DANTRIUM(TE code: AB)

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Elite Laboratories Inc FDA-2017-P-5954 Elite Laboratories, Inc. filed this petition under 21 CFR 314.122 requesting that the FDA determine Dantrolene Sodium 100 mg (ANDA 076856, manufactured by Impax Laboratories) is suitable as a Reference Listed Drug because the current Orange Book RLD, Dantrium 100 mg (Par Sterile Products LLC, NDA 17	Other	2017-09-27	Denied	Elite Laboratories Inc

Source: Regulations.gov. FDA citizen petitions matched by application number.

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.

Products (3)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Mar 1, 2005

No patent or exclusivity listings for this strength.

#002 — 50MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Mar 1, 2005

#003 — 100MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Mar 1, 2005