Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078561
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
ALPRAZOLAM ALPRAZOLAM 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
ALPRAZOLAM ALPRAZOLAM 2MG TABLET, ORALLY DISINTEGRATING;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
03/16/2010 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
12/16/2016 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-14 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/18/2016 SUPPL-13 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

ALPRAZOLAM

TABLET, ORALLY DISINTEGRATING;ORAL; 0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078561 ACTAVIS ELIZABETH
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078088 PAR PHARM

TABLET, ORALLY DISINTEGRATING;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078561 ACTAVIS ELIZABETH
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078088 PAR PHARM

TABLET, ORALLY DISINTEGRATING;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALPRAZOLAM ALPRAZOLAM 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078561 ACTAVIS ELIZABETH
ALPRAZOLAM ALPRAZOLAM 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078088 PAR PHARM

TABLET, ORALLY DISINTEGRATING;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALPRAZOLAM ALPRAZOLAM 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078561 ACTAVIS ELIZABETH
ALPRAZOLAM ALPRAZOLAM 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078088 PAR PHARM

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