اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
ALPRAZOLAM از شرکت ACTAVIS ELIZABETH
Abbreviated New Drug Application (ANDA): 074342
Company: ACTAVIS ELIZABETH
| 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 |
| ALPRAZOLAM | ALPRAZOLAM | 2MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/31/1993 | 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 |
|---|---|---|---|---|---|
| 12/31/2019 | SUPPL-47 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/08/2011 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/16/2003 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 02/15/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/02/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/30/2001 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/24/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/08/2000 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 11/15/1999 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/15/1999 | SUPPL-8 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 01/27/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/12/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/01/1994 | SUPPL-1 | Manufacturing (CMC) |
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 LTD |
| ALPRAZOLAM | ALPRAZOLAM | 0.25MG | TABLET;ORAL | Prescription | No | AB | 207507 | BRECKENRIDGE |
| ALPRAZOLAM | ALPRAZOLAM | 0.25MG | TABLET;ORAL | Prescription | No | AB | 200739 | NATCO PHARMA LTD |
| 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 | 090082 | SUN PHARM |
| ALPRAZOLAM | ALPRAZOLAM | 0.25MG | TABLET;ORAL | Prescription | No | AB | 090248 | VINTAGE PHARMS |
| 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 LTD |
| ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 207507 | BRECKENRIDGE |
| ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 200739 | NATCO PHARMA LTD |
| 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 | 090082 | SUN PHARM |
| ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 090248 | VINTAGE PHARMS |
| 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 LTD |
| ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET;ORAL | Prescription | No | AB | 207507 | BRECKENRIDGE |
| ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET;ORAL | Prescription | No | AB | 200739 | NATCO PHARMA LTD |
| 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 | 090082 | SUN PHARM |
| ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET;ORAL | Prescription | No | AB | 090248 | VINTAGE PHARMS |
| 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 LTD |
| ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 207507 | BRECKENRIDGE |
| ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 200739 | NATCO PHARMA LTD |
| 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 | 090082 | SUN PHARM |
| ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | No | AB | 090248 | VINTAGE PHARMS |
| XANAX | ALPRAZOLAM | 2MG | TABLET;ORAL | Prescription | Yes | AB | 018276 | UPJOHN |
حتما بخوانید : ALPRAZOLAM از شرکت ACTAVIS LABS FL INC
منبع : www.accessdata.fda.gov
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