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|
| Product |
Company |
Generic name |
TECFIDERA capsule 120 mg (NDA)
TECFIDERA capsule 240 mg (NDA)
Tecfidera kit (NDA)
|
Biogen Inc. |
dimethyl fumarate |
DIMETHYL FUMARATE capsule, delayed release 120 mg (ANDA)
DIMETHYL FUMARATE capsule, delayed release 240 mg (ANDA)
DIMETHYL FUMARATE kit (ANDA)
|
Accord Healthcare Inc. |
Dimethyl fumarate |
Dimethyl Fumarate capsule, delayed release 120 mg (ANDA)
Dimethyl Fumarate capsule, delayed release 240 mg (ANDA)
DIMETHYL FUMARATE kit (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Dimethyl Fumarate |
Dimethyl fumarate capsule, delayed release 120 mg (ANDA)
Dimethyl fumarate capsule, delayed release 240 mg (ANDA)
Dimethyl Fumarate kit (ANDA)
|
Ascend Laboratories, LLC |
Dimethyl fumarate |
Dimethyl Fumarate capsule, delayed release 120 mg (ANDA)
Dimethyl Fumarate capsule, delayed release 240 mg (ANDA)
|
Aurobindo Pharma Limited |
Dimethyl Fumarate |
DIMETHYL FUMARATE capsule, delayed release 120 mg (ANDA)
DIMETHYL FUMARATE capsule, delayed release 240 mg (ANDA)
DIMETHYL FUMARATE kit (ANDA)
|
Camber Pharmaceuticals, Inc. |
DIMETHYL FUMARATE |
DIMETHYL FUMARATE capsule, delayed release 120 mg (ANDA)
DIMETHYL FUMARATE capsule, delayed release 240 mg (ANDA)
DIMETHYL FUMARATE kit (ANDA)
|
Cipla USA Inc. |
DIMETHYL FUMARATE |
Dimethyl fumarate capsule, delayed release 120 mg (ANDA)
Dimethyl fumarate capsule, delayed release 240 mg (ANDA)
|
CivicaScript LLC |
Dimethyl fumarate |
Dimethyl Fumarate capsule, delayed release 120 mg (ANDA)
Dimethyl Fumarate capsule, delayed release 240 mg (ANDA)
|
Dr. Reddy's Laboratories Inc. |
Dimethyl fumarate |
dimethyl fumarate capsule, delayed release 240 mg (ANDA)
dimethyl fumarate capsule, delayed release 120 mg (ANDA)
|
Golden State Medical Supply, Inc. |
dimethyl fumarate |
Dimethyl Fumarate capsule, delayed release 120 mg (ANDA)
Dimethyl Fumarate capsule, delayed release 240 mg (ANDA)
Dimethyl Fumarate kit (ANDA)
|
MSN LABORATORIES PRIVATE LIMITED |
Dimethyl fumarate |
Dimethyl Fumarate capsule, delayed release 120 mg (ANDA)
Dimethyl Fumarate capsule, delayed release 240 mg (ANDA)
Dimethyl Fumarate kit (ANDA)
|
Macleods Pharmaceuticals Limited |
Dimethyl Fumarate |
Dimethyl fumarate capsule, delayed release 120 mg (ANDA)
Dimethyl fumarate capsule, delayed release 240 mg (ANDA)
|
Mylan Pharmaceuticals Inc. |
Dimethyl fumarate |
|
DIMETHYL FUMARATE capsule, delayed release 240 mg (ANDA)
|
Quallent Pharmaceuticals Health LLC |
DIMETHYL FUMARATE |
Dimethyl Fumarate capsule, delayed release 240 mg (ANDA)
Dimethyl Fumarate capsule, delayed release 120 mg (ANDA)
|
SOLA Pharmaceuticals, LLC |
Dimethyl Fumarate |
DIMETHYL FUMARATE capsule, delayed release 120 mg (ANDA)
DIMETHYL FUMARATE capsule, delayed release 240 mg (ANDA)
|
Solco Healthcare US, LLC |
dimethyl fumarate |
dimethyl fumarate capsule, delayed release 120 mg (ANDA)
dimethyl fumarate capsule, delayed release 240 mg (ANDA)
|
Upsher-Smith Laboratories, LLC |
dimethyl fumarate |
dimethyl fumarate capsule, delayed release 120 mg (ANDA)
dimethyl fumarate capsule, delayed release 240 mg (ANDA)
|
Zydus Lifesciences Limited |
dimethyl fumarate |
dimethyl fumarate capsule, delayed release 120 mg (ANDA)
dimethyl fumarate capsule, delayed release 240 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
dimethyl fumarate |
DIMETHYL FUMARATE capsule 120 mg (ANDA)
DIMETHYL FUMARATE capsule 240 mg (ANDA)
DIMETHYL FUMARATE kit (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
dimethyl-fumarate |
| |