Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076856
Company: IMPAX LABS
Company: IMPAX LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DANTROLENE SODIUM | DANTROLENE SODIUM | 25MG | CAPSULE;ORAL | Prescription | AB | No | No |
DANTROLENE SODIUM | DANTROLENE SODIUM | 50MG | CAPSULE;ORAL | Prescription | AB | No | No |
DANTROLENE SODIUM | DANTROLENE SODIUM | 100MG | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/01/2005 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/31/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
DANTROLENE SODIUM
CAPSULE;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DANTRIUM | DANTROLENE SODIUM | 25MG | CAPSULE;ORAL | Prescription | Yes | AB | 017443 | ENDO OPERATIONS |
DANTROLENE SODIUM | DANTROLENE SODIUM | 25MG | CAPSULE;ORAL | Prescription | No | AB | 076686 | ELITE LABS INC |
DANTROLENE SODIUM | DANTROLENE SODIUM | 25MG | CAPSULE;ORAL | Prescription | No | AB | 076856 | IMPAX LABS |
CAPSULE;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DANTRIUM | DANTROLENE SODIUM | 50MG | CAPSULE;ORAL | Prescription | Yes | AB | 017443 | ENDO OPERATIONS |
DANTROLENE SODIUM | DANTROLENE SODIUM | 50MG | CAPSULE;ORAL | Prescription | No | AB | 076686 | ELITE LABS INC |
DANTROLENE SODIUM | DANTROLENE SODIUM | 50MG | CAPSULE;ORAL | Prescription | No | AB | 076856 | IMPAX LABS |
CAPSULE;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DANTRIUM | DANTROLENE SODIUM | 100MG | CAPSULE;ORAL | Prescription | Yes | AB | 017443 | ENDO OPERATIONS |
DANTROLENE SODIUM | DANTROLENE SODIUM | 100MG | CAPSULE;ORAL | Prescription | No | AB | 076686 | ELITE LABS INC |
DANTROLENE SODIUM | DANTROLENE SODIUM | 100MG | CAPSULE;ORAL | Prescription | No | AB | 076856 | IMPAX LABS |