Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022544
Company: ASSERTIO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GRALISE GABAPENTIN 300MG TABLET;ORAL Prescription BX Yes Yes
GRALISE GABAPENTIN 600MG TABLET;ORAL Prescription BX 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
01/28/2011 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022544s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022544s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022544_gralise_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022544Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/06/2017 SUPPL-24 Labeling-Container/Carton Labels

Label is not available on this site.

01/09/2017 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/09/2013 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/10/2013 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/31/2013 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/09/2013 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/28/2013 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/13/2013 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/25/2013 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/31/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/27/2013 SUPPL-12 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022544s012lbl.pdf
11/30/2012 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/08/2012 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022544s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022544Orig1s008ltr.pdf
01/31/2012 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022544s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022544s006ltr.pdf
04/28/2011 SUPPL-3 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022544s003ltr.pdf
06/28/2011 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022544s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022544s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/27/2013 SUPPL-12 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022544s012lbl.pdf
08/08/2012 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022544s008lbl.pdf
01/31/2012 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022544s006lbl.pdf
06/28/2011 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022544s002lbl.pdf
01/28/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022544s000lbl.pdf

GRALISE

There are no Therapeutic Equivalents.

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