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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010596
Company: PARKE DAVIS

Medication Guide

Products on NDA 010596

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CELONTIN	METHSUXIMIDE	150MG	CAPSULE;ORAL	Discontinued	None	Yes	No
CELONTIN	METHSUXIMIDE	300MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010596

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/08/1957	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
06/15/2011	SUPPL-23	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010596s023ltr.pdf
10/11/2010	SUPPL-22	Labeling, REMS-Proposal	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010596s22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010596s022ltr.pdf
04/23/2009	SUPPL-21	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010596s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010596s021ltr.pdf
04/17/2002	SUPPL-17	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10596s17ltr.pdf
04/11/2000	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
04/12/1999	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
10/20/1997	SUPPL-13	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/09/2001	SUPPL-12	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10596s9s12ltr.pdf
12/11/1995	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
01/24/1990	SUPPL-10	Labeling		Label is not available on this site.
04/09/2001	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10596s9s12ltr.pdf
08/20/1987	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
01/27/1981	SUPPL-7	Manufacturing (CMC)-Formulation		Label is not available on this site.
01/27/1981	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/23/1977	SUPPL-4	Labeling		Label is not available on this site.

Labels for NDA 010596

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/11/2010	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010596s22lbl.pdf
10/11/2010	SUPPL-22	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010596s22lbl.pdf
04/23/2009	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010596s021lbl.pdf

Therapeutic Equivalents for NDA 010596

CELONTIN

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CELONTIN	METHSUXIMIDE	300MG	CAPSULE;ORAL	Prescription	Yes	AB	010596	PARKE DAVIS
METHSUXIMIDE	METHSUXIMIDE	300MG	CAPSULE;ORAL	Prescription	No	AB	217213	NOVITIUM PHARMA

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