Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040430
Company: BIONPHARMA
Company: BIONPHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ETHOSUXIMIDE | ETHOSUXIMIDE | 250MG | 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 |
---|---|---|---|---|---|---|---|
10/28/2002 | 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 |
---|---|---|---|---|---|
02/16/2022 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
04/01/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
01/07/2014 | SUPPL-8 | Labeling-Medication Guide |
Label is not available on this site. |
||
10/19/2012 | SUPPL-7 | REMS-Modified |
Label is not available on this site. |
||
12/27/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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12/10/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
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03/03/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
ETHOSUXIMIDE
CAPSULE;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ETHOSUXIMIDE | ETHOSUXIMIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 040430 | BIONPHARMA |
ETHOSUXIMIDE | ETHOSUXIMIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 040686 | EPIC PHARMA LLC |
ETHOSUXIMIDE | ETHOSUXIMIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 200892 | HERITAGE PHARMS INC |
ETHOSUXIMIDE | ETHOSUXIMIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 210654 | PURACAP PHARM LLC |
ETHOSUXIMIDE | ETHOSUXIMIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 211928 | STRIDES PHARMA |
ZARONTIN | ETHOSUXIMIDE | 250MG | CAPSULE;ORAL | Prescription | Yes | AB | 012380 | PARKE DAVIS |