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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078449
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
ALPRAZOLAM ALPRAZOLAM 2MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
ALPRAZOLAM ALPRAZOLAM 3MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
ALPRAZOLAM ALPRAZOLAM 1MG TABLET, EXTENDED RELEASE;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
11/12/2008 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
01/28/2013 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

12/23/2015 SUPPL-2 Labeling

Label is not available on this site.

12/23/2015 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

ALPRAZOLAM

TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL Prescription No AB 078056 ACTAVIS ELIZABETH
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078387 AMNEAL PHARMS NY
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078469 ANCHEN PHARMS
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078449 APOTEX INC
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090871 AUROBINDO PHARMA
XANAX XR ALPRAZOLAM 0.5MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021434 UPJOHN

TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL Prescription No AB 078056 ACTAVIS ELIZABETH
ALPRAZOLAM ALPRAZOLAM 2MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078387 AMNEAL PHARMS NY
ALPRAZOLAM ALPRAZOLAM 2MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078469 ANCHEN PHARMS
ALPRAZOLAM ALPRAZOLAM 2MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078449 APOTEX INC
ALPRAZOLAM ALPRAZOLAM 2MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090871 AUROBINDO PHARMA
XANAX XR ALPRAZOLAM 2MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021434 UPJOHN

TABLET, EXTENDED RELEASE;ORAL; 3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALPRAZOLAM ALPRAZOLAM 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078056 ACTAVIS ELIZABETH
ALPRAZOLAM ALPRAZOLAM 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078387 AMNEAL PHARMS NY
ALPRAZOLAM ALPRAZOLAM 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078469 ANCHEN PHARMS
ALPRAZOLAM ALPRAZOLAM 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078449 APOTEX INC
ALPRAZOLAM ALPRAZOLAM 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090871 AUROBINDO PHARMA
XANAX XR ALPRAZOLAM 3MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021434 UPJOHN

TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL Prescription No AB 078056 ACTAVIS ELIZABETH
ALPRAZOLAM ALPRAZOLAM 1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078387 AMNEAL PHARMS NY
ALPRAZOLAM ALPRAZOLAM 1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078469 ANCHEN PHARMS
ALPRAZOLAM ALPRAZOLAM 1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078449 APOTEX INC
ALPRAZOLAM ALPRAZOLAM 1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090871 AUROBINDO PHARMA
XANAX XR ALPRAZOLAM 1MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021434 UPJOHN
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