Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018276
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code
XANAX ALPRAZOLAM 0.25MG TABLET;ORAL Prescription Yes AB
XANAX ALPRAZOLAM 0.5MG TABLET;ORAL Prescription Yes AB
XANAX ALPRAZOLAM 1MG TABLET;ORAL Prescription Yes AB
XANAX ALPRAZOLAM 2MG TABLET;ORAL Prescription Yes AB
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/16/1981 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Submission Classification Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/16/2016 SUPPL-52 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018276s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018276Orig1s052,021434Orig1s016ltr.pdf
08/08/2014 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

08/23/2011 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018276s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018276s045,021434s007ltr.pdf
06/01/2011 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018276s044,021434s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018276s044,021434s006ltr.pdf
04/02/2004 SUPPL-39 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18276slr038,039,21434slr001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018276_S039_Xanax Tablets_APPROVAL PACKAGES.pdf
04/02/2004 SUPPL-38 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18276slr038,039,21434slr001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018276_S038_Xanax Tablets_APPROVAL PACKAGE.pdf
11/07/2002 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

11/16/1999 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/02/2000 SUPPL-35 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018276_S035_Xanax Tablets_APPROVAL PACKAGE.pdf
11/24/1998 SUPPL-34 Labeling

Label is not available on this site.

12/20/1996 SUPPL-33 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018276ap.pdf
04/18/1996 SUPPL-32 Labeling

Label is not available on this site.

09/14/1993 SUPPL-31 Labeling

Label is not available on this site.

12/01/1992 SUPPL-28 Labeling

Label is not available on this site.

05/21/1993 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1993 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

06/22/1994 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1989 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/22/1990 SUPPL-21 Labeling

Label is not available on this site.

08/03/1988 SUPPL-20 Labeling

Label is not available on this site.

07/26/1988 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/25/1988 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/06/1990 SUPPL-17 Efficacy-New Indication

Label is not available on this site.

10/23/1990 SUPPL-16 Labeling

Label is not available on this site.

11/06/1990 SUPPL-15 Labeling

Label is not available on this site.

08/17/1988 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1987 SUPPL-13 Labeling

Label is not available on this site.

07/16/1986 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/28/1987 SUPPL-10 Labeling

Label is not available on this site.

03/27/1986 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/12/1987 SUPPL-7 Labeling

Label is not available on this site.

11/27/1985 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/08/1987 SUPPL-5 Labeling

Label is not available on this site.

12/08/1983 SUPPL-3 Labeling

Label is not available on this site.

11/18/1983 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Submission Classification or
Approval
Type
Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/16/2016 SUPPL-52 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018276s052lbl.pdf
12/16/2016 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018276s052lbl.pdf
08/23/2011 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018276s045lbl.pdf
06/01/2011 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018276s044,021434s006lbl.pdf

XANAX

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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