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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018264
Company: PAR STERILE PRODUCTS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DANTRIUM DANTROLENE SODIUM 20MG/VIAL INJECTABLE;INJECTION Prescription AP 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
09/19/1979 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; 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
04/02/2024 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018264s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018264Orig1s042ltr.pdf
10/09/2008 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018264s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018264s025ltr.pdf
10/01/2001 SUPPL-22 Labeling

Label is not available on this site.
07/12/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
08/18/2000 SUPPL-19 Labeling

Label is not available on this site.
02/21/1989 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
06/28/1988 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
06/28/1989 SUPPL-15 Labeling

Label is not available on this site.
12/11/1987 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
06/04/1987 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
08/07/1985 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
05/12/1987 SUPPL-11 Efficacy-New Indication

Label is not available on this site.
08/06/1985 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
02/15/1986 SUPPL-9 Labeling

Label is not available on this site.
05/12/1987 SUPPL-8 Labeling

Label is not available on this site.
02/12/1982 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
10/01/1981 SUPPL-6 Labeling

Label is not available on this site.
05/30/1981 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
01/14/1981 SUPPL-4 Labeling

Label is not available on this site.
02/26/1982 SUPPL-3 Efficacy

Label is not available on this site.
06/16/1980 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
02/07/1980 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/02/2024 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018264s042lbl.pdf
10/09/2008 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018264s025lbl.pdf

DANTRIUM

INJECTABLE;INJECTION; 20MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DANTRIUM DANTROLENE SODIUM 20MG/VIAL INJECTABLE;INJECTION Prescription Yes AP 018264 PAR STERILE PRODUCTS
DANTROLENE SODIUM DANTROLENE SODIUM 20MG/VIAL INJECTABLE;INJECTION Prescription No AP 204762 HIKMA
REVONTO DANTROLENE SODIUM 20MG/VIAL INJECTABLE;INJECTION Prescription No AP 078378 USWM
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