Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076686
Company: ELITE LABS INC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/24/2005 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
02/27/2019 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

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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