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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080258
Company: PARKE-DAVIS

Products on ANDA 080258

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZARONTIN	ETHOSUXIMIDE	250MG/5ML	SYRUP;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080258

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.

Labels for ANDA 080258

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

Therapeutic Equivalents for ANDA 080258

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	CHARTWELL RX
ETHOSUXIMIDE	ETHOSUXIMIDE	250MG/5ML	SYRUP;ORAL	Prescription	No	AA	040253	PHARM ASSOC
ZARONTIN	ETHOSUXIMIDE	250MG/5ML	SYRUP;ORAL	Prescription	Yes	AA	080258	PARKE-DAVIS

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