Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074215
Company: MYLAN
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
ALPRAZOLAM ALPRAZOLAM 2MG 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
01/27/1994 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
09/27/2011 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

06/01/2012 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

06/28/2008 SUPPL-18 Labeling

Label is not available on this site.

04/03/2002 SUPPL-6 Labeling

Label is not available on this site.

10/18/2000 SUPPL-5 Labeling

Label is not available on this site.

05/06/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/03/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/07/1997 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

TABLET;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;ORAL Prescription No AB 074342 ACTAVIS ELIZABETH
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;ORAL Prescription No AB 077741 APOTEX INC
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;ORAL Prescription No AB 203346 AUROBINDO PHARMA LTD
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;ORAL Prescription No AB 074174 DAVA INTL INC
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;ORAL Prescription No AB 074215 MYLAN
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;ORAL Prescription No AB 074046 MYLAN PHARMS INC
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;ORAL Prescription No AB 200739 NATCO PHARMA LTD
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;ORAL Prescription No AB 074909 SANDOZ
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;ORAL Prescription No AB 090082 SUN PHARMA GLOBAL
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;ORAL Prescription No AB 078491 VINTAGE
ALPRAZOLAM ALPRAZOLAM 2MG TABLET;ORAL Prescription No AB 090248 VINTAGE PHARMS
XANAX ALPRAZOLAM 2MG TABLET;ORAL Prescription Yes AB 018276 PHARMACIA AND UPJOHN

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