Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078378
Company: USWM

Products on ANDA 078378

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078378

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
11/22/2024	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 078378

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	PH HEALTH
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