Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078088
Company: PAR PHARM
Company: PAR PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALPRAZOLAM | ALPRAZOLAM | 0.25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
| ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
| ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | Yes |
| ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET, ORALLY DISINTEGRATING;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 |
|---|---|---|---|---|---|---|---|
| 01/09/2009 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078088TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078088ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/17/2023 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2021 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-7 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/28/2016 | SUPPL-4 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/27/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
ALPRAZOLAM
TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078561 | ACTAVIS ELIZABETH |
| ALPRAZOLAM | ALPRAZOLAM | 0.25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078088 | PAR PHARM |
TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078561 | ACTAVIS ELIZABETH |
| ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078088 | PAR PHARM |
TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078561 | ACTAVIS ELIZABETH |
| ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078088 | PAR PHARM |
TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078561 | ACTAVIS ELIZABETH |
| ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078088 | PAR PHARM |