Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078088
Company: PAR PHARM
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 Yes
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
01/09/2009 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078088ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078088TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/16/2016 SUPPL-7 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

01/28/2016 SUPPL-4 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

09/27/2011 SUPPL-3 Labeling-Package Insert

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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