Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078378
Company: US WORLDMEDS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REVONTO DANTROLENE SODIUM 20MG/VIAL INJECTABLE;INJECTION Prescription AP No 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
07/24/2007 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078378s000LTR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/27/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

02/16/2010 SUPPL-6 Labeling-Proprietary Name Change, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

02/16/2010 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

02/16/2010 SUPPL-4 Labeling

Label is not available on this site.

REVONTO

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 PHARMS
REVONTO DANTROLENE SODIUM 20MG/VIAL INJECTABLE;INJECTION Prescription No AP 078378 US WORLDMEDS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English