Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020648
Company: VALEANT PHARMS NORTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIASTAT DIAZEPAM 2.5MG/0.5ML (5MG/ML) GEL;RECTAL Prescription None Yes No
DIASTAT DIAZEPAM 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** GEL;RECTAL Discontinued None Yes No
DIASTAT DIAZEPAM 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** GEL;RECTAL Discontinued None Yes No
DIASTAT DIAZEPAM 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** GEL;RECTAL Discontinued None Yes No
DIASTAT DIAZEPAM 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** GEL;RECTAL Discontinued None Yes No
DIASTAT ACUDIAL DIAZEPAM 20MG/4ML (5MG/ML) GEL;RECTAL Prescription None Yes Yes
DIASTAT ACUDIAL DIAZEPAM 10MG/2ML (5MG/ML) GEL;RECTAL Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/29/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/16/2016 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020648s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020648Orig1s014ltr.pdf
10/27/2016 SUPPL-13 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020648s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020648Orig1s013ltr.pdf
12/16/2014 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020648s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020648Orig1s012ltr.pdf
08/29/2013 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020648Orig1s009ltr.pdf
09/15/2005 SUPPL-8 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
Patient Package Insert (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020648s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020648s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020648s008ppi.pdf
06/18/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/17/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/31/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/11/2001 SUPPL-2 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20648S2ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020648_S002_DIASTAT_AP.pdf
08/25/1998 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/16/2016 SUPPL-14 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020648s014lbl.pdf
12/16/2016 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020648s014lbl.pdf
10/27/2016 SUPPL-13 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020648s013lbl.pdf
12/16/2014 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020648s012lbl.pdf
09/15/2005 SUPPL-8 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020648s008lbl.pdf

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