Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012380
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
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 REMS-Proposal, Labeling 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
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 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012380s032lbl.pdf
09/14/2010 SUPPL-32 Labeling 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 040686 AKORN
ETHOSUXIMIDE ETHOSUXIMIDE 250MG CAPSULE;ORAL Prescription No AB 040430 BIONPHARMA INC
ETHOSUXIMIDE ETHOSUXIMIDE 250MG CAPSULE;ORAL Prescription No AB 200892 HERITAGE PHARMS INC
ETHOSUXIMIDE ETHOSUXIMIDE 250MG CAPSULE;ORAL Prescription No AB 211928 STRIDES PHARMA
ZARONTIN ETHOSUXIMIDE 250MG CAPSULE;ORAL Prescription Yes AB 012380 PARKE DAVIS

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