Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021434
Company: UPJOHN
Company: 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 |
---|---|---|---|---|---|
01/13/2023 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021434s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018276Orig1s059;021434Orig1s022ltr.pdf | |
02/05/2021 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021434s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018276Orig1s058; 021434Orig1s021ltr.pdf | |
03/01/2021 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021434s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018276Orig1s055, 021434Orig1s018ltr.pdf | |
12/16/2016 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
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 |
---|---|---|---|---|---|
01/13/2023 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021434s022lbl.pdf | |
03/01/2021 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021434s018lbl.pdf | |
02/05/2021 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021434s021lbl.pdf | |
12/16/2016 | SUPPL-16 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021434s016lbl.pdf | |
12/16/2016 | SUPPL-16 | Labeling-Package Insert | 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 | 078449 | APOTEX INC |
ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090871 | AUROBINDO PHARMA |
XANAX XR | ALPRAZOLAM | 0.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021434 | 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 | 078449 | APOTEX INC |
ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090871 | AUROBINDO PHARMA |
XANAX XR | ALPRAZOLAM | 1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021434 | 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 | 078449 | APOTEX INC |
ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090871 | AUROBINDO PHARMA |
XANAX XR | ALPRAZOLAM | 2MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021434 | 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 | 078449 | APOTEX INC |
ALPRAZOLAM | ALPRAZOLAM | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090871 | AUROBINDO PHARMA |
XANAX XR | ALPRAZOLAM | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021434 | UPJOHN |