Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021434
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XANAX XR ALPRAZOLAM 0.5MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
XANAX XR ALPRAZOLAM 1MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
XANAX XR ALPRAZOLAM 2MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
XANAX XR ALPRAZOLAM 3MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/17/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021434lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21434ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-434_Xanax.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/16/2016 SUPPL-16 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021434s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018276Orig1s052,021434Orig1s016ltr.pdf
04/07/2016 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/04/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/23/2011 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021434s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018276s045,021434s007ltr.pdf
06/01/2011 SUPPL-6 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-1 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/2004/021434_S001_Xanax_APPROVAL PACKAGE.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/16/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021434s016lbl.pdf
12/16/2016 SUPPL-16 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021434s016lbl.pdf
08/23/2011 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021434s007lbl.pdf
06/01/2011 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018276s044,021434s006lbl.pdf
01/17/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021434lbl.pdf

XANAX XR

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
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
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
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
XANAX XR ALPRAZOLAM 3MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021434 PHARMACIA AND UPJOHN

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