Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090871
Company: AUROBINDO PHARMA LTD
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 1MG 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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/07/2011 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
09/19/2013 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

08/22/2011 SUPPL-1 Labeling-Package Insert

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 077725 ANI PHARMS INC
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 LTD
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078489 HERITAGE PHARMS INC
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077391 MYLAN
XANAX XR ALPRAZOLAM 0.5MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021434 PHARMACIA AND 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 077725 ANI PHARMS INC
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 LTD
ALPRAZOLAM ALPRAZOLAM 1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078489 HERITAGE PHARMS INC
ALPRAZOLAM ALPRAZOLAM 1MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077391 MYLAN
XANAX XR ALPRAZOLAM 1MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021434 PHARMACIA AND 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 077725 ANI PHARMS INC
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 LTD
ALPRAZOLAM ALPRAZOLAM 2MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078489 HERITAGE PHARMS INC
ALPRAZOLAM ALPRAZOLAM 2MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077391 MYLAN
XANAX XR ALPRAZOLAM 2MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021434 PHARMACIA AND 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 077725 ANI PHARMS INC
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 LTD
ALPRAZOLAM ALPRAZOLAM 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078489 HERITAGE PHARMS INC
ALPRAZOLAM ALPRAZOLAM 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077391 MYLAN
XANAX XR ALPRAZOLAM 3MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021434 PHARMACIA AND UPJOHN

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