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
ACETAZOLAMIDE از شرکت BRECKENRIDGE
Abbreviated New Drug Application (ANDA): 207503
Company: BRECKENRIDGE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription |
AB |
No | No |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/30/2020 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
ACETAZOLAMIDE
TABLET;ORAL; 125MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | No | AB | 211372 | APPCO |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | No | AB | 207503 | BRECKENRIDGE |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | No | AB | 211556 | EYWA PHARMA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | No | AB | 205530 | HERITAGE PHARMA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | No | AB | 214282 | MANKIND PHARMA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | No | AB | 210588 | NOVITIUM PHARMA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | No | AB | 215101 | RUBICON |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | No | AB | 209734 | STRIDES PHARMA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 125MG | TABLET;ORAL | Prescription | No | AB | 040195 | TARO |
TABLET;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 211372 | APPCO |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 207503 | BRECKENRIDGE |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 211556 | EYWA PHARMA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 205530 | HERITAGE PHARMA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 084840 | LANNETT |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 214282 | MANKIND PHARMA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 210588 | NOVITIUM PHARMA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 215101 | RUBICON |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 209734 | STRIDES PHARMA |
| ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | TABLET;ORAL | Prescription | No | AB | 040195 | TARO |
نظرات کاربران