Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074112
Company: SANDOZ
Company: SANDOZ
| 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/29/1995 | 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 |
|---|---|---|---|---|---|
| 06/30/2023 | SUPPL-38 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/15/2021 | SUPPL-36 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/31/2019 | SUPPL-31 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/29/2012 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2014 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/26/2008 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 12/09/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/19/2001 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 10/01/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/16/2001 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/13/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1998 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/09/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1997 | 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 |
| 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 |