Drugs@FDA: FDA-Approved Drugs
Company: PARKE-DAVIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZARONTIN | ETHOSUXIMIDE | 250MG/5ML | SYRUP;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
02/13/1974 | 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 |
---|---|---|---|---|---|
10/29/2021 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
10/29/2021 | SUPPL-32 | Labeling-Medication Guide |
Label is not available on this site. |
||
01/16/2014 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/080258Orig1s031.pdf | |
10/25/2012 | SUPPL-30 | REMS-Modified |
Label is not available on this site. |
||
01/16/2014 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/080258Orig1s031.pdf | |
04/25/2011 | SUPPL-28 | REMS-Proposal |
Label is not available on this site. |
||
11/20/2009 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
11/20/2009 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
05/06/2009 | SUPPL-25 | Labeling, REMS-Proposal |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/080258s025lbl.pdf | |
10/03/2006 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
10/27/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/22/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/13/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/28/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/16/2014 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/080258Orig1s031.pdf | |
01/16/2014 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/080258Orig1s031.pdf | |
05/06/2009 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/080258s025lbl.pdf | |
05/06/2009 | SUPPL-25 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/080258s025lbl.pdf |
ZARONTIN
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 |