Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080258
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 No 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
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 REMS-Proposal, Labeling 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 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/080258s025lbl.pdf
05/06/2009 SUPPL-25 Labeling 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
ETHOSUXIMIDE ETHOSUXIMIDE 250MG/5ML SYRUP;ORAL Prescription No AA 081306 TEVA PHARMS
ZARONTIN ETHOSUXIMIDE 250MG/5ML SYRUP;ORAL Prescription No AA 080258 PARKE-DAVIS

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