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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076856
Company: IMPAX LABS

Products on ANDA 076856

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DANTROLENE SODIUM	DANTROLENE SODIUM	25MG	CAPSULE;ORAL	Prescription	AB	No	No
DANTROLENE SODIUM	DANTROLENE SODIUM	50MG	CAPSULE;ORAL	Prescription	AB	No	No
DANTROLENE SODIUM	DANTROLENE SODIUM	100MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076856

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/01/2005	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/31/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076856

DANTROLENE SODIUM

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DANTRIUM	DANTROLENE SODIUM	25MG	CAPSULE;ORAL	Prescription	Yes	AB	017443	PAR STERILE PRODUCTS
DANTROLENE SODIUM	DANTROLENE SODIUM	25MG	CAPSULE;ORAL	Prescription	No	AB	076686	ELITE LABS INC
DANTROLENE SODIUM	DANTROLENE SODIUM	25MG	CAPSULE;ORAL	Prescription	No	AB	076856	IMPAX LABS

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DANTRIUM	DANTROLENE SODIUM	50MG	CAPSULE;ORAL	Prescription	Yes	AB	017443	PAR STERILE PRODUCTS
DANTROLENE SODIUM	DANTROLENE SODIUM	50MG	CAPSULE;ORAL	Prescription	No	AB	076686	ELITE LABS INC
DANTROLENE SODIUM	DANTROLENE SODIUM	50MG	CAPSULE;ORAL	Prescription	No	AB	076856	IMPAX LABS

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DANTRIUM	DANTROLENE SODIUM	100MG	CAPSULE;ORAL	Prescription	Yes	AB	017443	PAR STERILE PRODUCTS
DANTROLENE SODIUM	DANTROLENE SODIUM	100MG	CAPSULE;ORAL	Prescription	No	AB	076686	ELITE LABS INC
DANTROLENE SODIUM	DANTROLENE SODIUM	100MG	CAPSULE;ORAL	Prescription	No	AB	076856	IMPAX LABS

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