Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018276
Company: UPJOHN
Company: UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| XANAX | ALPRAZOLAM | 0.25MG | TABLET;ORAL | Prescription | AB | Yes | No |
| XANAX | ALPRAZOLAM | 0.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| XANAX | ALPRAZOLAM | 1MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| XANAX | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 10/16/1981 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/13/2023 | SUPPL-59 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018276s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018276Orig1s059;021434Orig1s022ltr.pdf | |
| 02/05/2021 | SUPPL-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018276s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018276Orig1s058; 021434Orig1s021ltr.pdf | |
| 03/01/2021 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018276s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018276Orig1s055, 021434Orig1s018ltr.pdf | |
| 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 | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/13/2023 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018276s059lbl.pdf | |
| 03/01/2021 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018276s055lbl.pdf | |
| 02/05/2021 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018276s058lbl.pdf | |
| 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 |
| ALPRAZOLAM | ALPRAZOLAM | 0.25MG | TABLET;ORAL | Prescription | No | AB | 207507 | CHARTWELL RX |
| ALPRAZOLAM | ALPRAZOLAM | 0.25MG | TABLET;ORAL | Prescription | No | AB | 200739 | NATCO |
| ALPRAZOLAM | ALPRAZOLAM | 0.25MG | TABLET;ORAL | Prescription | No | AB | 074174 | NOVITIUM PHARMA |
| ALPRAZOLAM | ALPRAZOLAM | 0.25MG | TABLET;ORAL | Prescription | No | AB | 074112 | SANDOZ |
| ALPRAZOLAM | ALPRAZOLAM | 0.25MG | TABLET;ORAL | Prescription | No | AB | 090248 | STRIDES PHARMA |
| ALPRAZOLAM | ALPRAZOLAM | 0.25MG | TABLET;ORAL | Prescription | No | AB | 090082 | SUN PHARM |
| XANAX | ALPRAZOLAM | 0.25MG | TABLET;ORAL | Prescription | Yes | AB | 018276 | 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 |
| ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 207507 | CHARTWELL RX |
| ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 200739 | NATCO |
| ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 074174 | NOVITIUM PHARMA |
| ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 074112 | SANDOZ |
| ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 090248 | STRIDES PHARMA |
| ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 090082 | SUN PHARM |
| XANAX | ALPRAZOLAM | 0.5MG | TABLET;ORAL | Prescription | Yes | AB | 018276 | 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 |
| ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET;ORAL | Prescription | No | AB | 207507 | CHARTWELL RX |
| ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET;ORAL | Prescription | No | AB | 200739 | NATCO |
| ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET;ORAL | Prescription | No | AB | 074174 | NOVITIUM PHARMA |
| ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET;ORAL | Prescription | No | AB | 074112 | SANDOZ |
| ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET;ORAL | Prescription | No | AB | 090248 | STRIDES PHARMA |
| ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET;ORAL | Prescription | No | AB | 090082 | SUN PHARM |
| XANAX | ALPRAZOLAM | 1MG | TABLET;ORAL | Prescription | Yes | AB | 018276 | 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 |
| ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 207507 | CHARTWELL RX |
| ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 200739 | NATCO |
| ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 074174 | NOVITIUM PHARMA |
| ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 074909 | SANDOZ |
| ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 090248 | STRIDES PHARMA |
| ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 090082 | SUN PHARM |
| XANAX | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | Yes | AB | 018276 | UPJOHN |