Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040506
Company: MIKART
Company: MIKART
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ETHOSUXIMIDE | ETHOSUXIMIDE | 250MG/5ML | SYRUP;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
12/22/2003 | 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 |
---|---|---|---|---|---|
01/10/2014 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
12/10/2009 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
08/15/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
ETHOSUXIMIDE
SYRUP;ORAL; 250MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ETHOSUXIMIDE | ETHOSUXIMIDE | 250MG/5ML | SYRUP;ORAL | Prescription | No | AA | 040506 | MIKART |
ETHOSUXIMIDE | ETHOSUXIMIDE | 250MG/5ML | SYRUP;ORAL | Prescription | No | AA | 040253 | PHARM ASSOC |
ZARONTIN | ETHOSUXIMIDE | 250MG/5ML | SYRUP;ORAL | Prescription | Yes | AA | 080258 | PARKE-DAVIS |