Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074112
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription AB No No
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription AB No No
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;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
12/29/1995 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
11/29/2012 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

10/31/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/26/2008 SUPPL-22 Labeling

Label is not available on this site.

12/09/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/2001 SUPPL-13 Labeling

Label is not available on this site.

10/01/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/2001 SUPPL-11 Labeling

Label is not available on this site.

09/13/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/01/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/01/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/27/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/08/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/09/1998 SUPPL-4 Labeling

Label is not available on this site.

06/09/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/25/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/29/1997 SUPPL-1 Labeling

Label is not available on this site.

ALPRAZOLAM

TABLET;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;ORAL Prescription No AB 074342 ACTAVIS ELIZABETH
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription No AB 077741 APOTEX INC
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription No AB 203346 AUROBINDO PHARMA LTD
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription No AB 074174 DAVA INTL INC
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription No AB 074215 MYLAN
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription No AB 074046 MYLAN PHARMS INC
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription No AB 200739 NATCO PHARMA LTD
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription No AB 074112 SANDOZ
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription No AB 090082 SUN PHARMA GLOBAL
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription No AB 078491 VINTAGE
ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET;ORAL Prescription No AB 090248 VINTAGE PHARMS
XANAX ALPRAZOLAM 0.25MG TABLET;ORAL Prescription Yes AB 018276 PHARMACIA AND UPJOHN

TABLET;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;ORAL Prescription No AB 074342 ACTAVIS ELIZABETH
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription No AB 077741 APOTEX INC
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription No AB 203346 AUROBINDO PHARMA LTD
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription No AB 074174 DAVA INTL INC
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription No AB 074215 MYLAN
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription No AB 074046 MYLAN PHARMS INC
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription No AB 200739 NATCO PHARMA LTD
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription No AB 074112 SANDOZ
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription No AB 090082 SUN PHARMA GLOBAL
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription No AB 078491 VINTAGE
ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET;ORAL Prescription No AB 090248 VINTAGE PHARMS
XANAX ALPRAZOLAM 0.5MG TABLET;ORAL Prescription Yes AB 018276 PHARMACIA AND UPJOHN

TABLET;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;ORAL Prescription No AB 074342 ACTAVIS ELIZABETH
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription No AB 077741 APOTEX INC
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription No AB 203346 AUROBINDO PHARMA LTD
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription No AB 074174 DAVA INTL INC
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription No AB 074215 MYLAN
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription No AB 074046 MYLAN PHARMS INC
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription No AB 200739 NATCO PHARMA LTD
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription No AB 074112 SANDOZ
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription No AB 090082 SUN PHARMA GLOBAL
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription No AB 078491 VINTAGE
ALPRAZOLAM ALPRAZOLAM 1MG TABLET;ORAL Prescription No AB 090248 VINTAGE PHARMS
XANAX ALPRAZOLAM 1MG TABLET;ORAL Prescription Yes AB 018276 PHARMACIA AND UPJOHN

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