Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 010596
Company: PARKE DAVIS
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 None 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
02/08/1957 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.

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

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