Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012380
Company: PARKE DAVIS
Company: PARKE DAVIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZARONTIN | ETHOSUXIMIDE | 250MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/02/1960 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/28/2021 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/012380s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/012380Orig1s037ltr.pdf | |
| 05/17/2016 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012380s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/012380Orig1s036ltr.pdf | |
| 05/03/2012 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012380s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/012380s034ltr.pdf | |
| 06/15/2011 | SUPPL-33 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012380s033ltr.pdf |
| 09/14/2010 | SUPPL-32 | Labeling, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012380s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012380s032ltr.pdf | |
| 04/23/2009 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012380s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/012380s031ltr.pdf | |
| 09/01/2006 | SUPPL-30 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012380s030ltr.pdf |
| 04/19/2002 | SUPPL-29 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12380s029.pdf |
| 09/22/2000 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/2000 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/2001 | SUPPL-25 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12380S25ltr.pdf |
| 02/22/1996 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/09/2001 | SUPPL-23 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12380S25ltr.pdf |
| 04/09/2001 | SUPPL-22 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12380S25ltr.pdf |
| 01/08/1991 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1984 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/1983 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/03/1982 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/09/1981 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1981 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1981 | SUPPL-15 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/03/1981 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1980 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1980 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/28/2021 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/012380s037lbl.pdf | |
| 05/17/2016 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012380s036lbl.pdf | |
| 05/03/2012 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012380s034lbl.pdf | |
| 09/14/2010 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012380s032lbl.pdf | |
| 09/14/2010 | SUPPL-32 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012380s032lbl.pdf | |
| 04/23/2009 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012380s031lbl.pdf |
ZARONTIN
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 |