Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078056
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| ALPRAZOLAM | ALPRAZOLAM | 3MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 02/13/2007 | 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 |
|---|---|---|---|---|---|
| 06/23/2023 | SUPPL-21 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2023 | SUPPL-20 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/23/2023 | SUPPL-18 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/22/2011 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
ALPRAZOLAM
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 |