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
BOSENTAN از شرکت PAR PHARM INC
Abbreviated New Drug Application (ANDA): 205699
Company: PAR PHARM INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BOSENTAN | BOSENTAN | 62.5MG | TABLET;ORAL | Prescription |
AB |
No | No |
| BOSENTAN | BOSENTAN | 125MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/26/2019 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205699Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/04/2019 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
BOSENTAN
TABLET;ORAL; 62.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BOSENTAN | BOSENTAN | 62.5MG | TABLET;ORAL | Prescription | No | AB | 209742 | AMNEAL PHARMS CO |
| BOSENTAN | BOSENTAN | 62.5MG | TABLET;ORAL | Prescription | No | AB | 208695 | HIKMA PHARMS |
| BOSENTAN | BOSENTAN | 62.5MG | TABLET;ORAL | Prescription | No | AB | 205699 | PAR PHARM INC |
| BOSENTAN | BOSENTAN | 62.5MG | TABLET;ORAL | Prescription | No | AB | 209324 | SUN PHARM |
| BOSENTAN | BOSENTAN | 62.5MG | TABLET;ORAL | Prescription | No | AB | 207110 | WATSON LABS INC |
| BOSENTAN | BOSENTAN | 62.5MG | TABLET;ORAL | Prescription | No | AB | 207760 | ZYDUS PHARMS |
| TRACLEER | BOSENTAN | 62.5MG | TABLET;ORAL | Prescription | Yes | AB | 021290 | ACTELION |
TABLET;ORAL; 125MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BOSENTAN | BOSENTAN | 125MG | TABLET;ORAL | Prescription | No | AB | 209742 | AMNEAL PHARMS CO |
| BOSENTAN | BOSENTAN | 125MG | TABLET;ORAL | Prescription | No | AB | 208695 | HIKMA PHARMS |
| BOSENTAN | BOSENTAN | 125MG | TABLET;ORAL | Prescription | No | AB | 205699 | PAR PHARM INC |
| BOSENTAN | BOSENTAN | 125MG | TABLET;ORAL | Prescription | No | AB | 209324 | SUN PHARM |
| BOSENTAN | BOSENTAN | 125MG | TABLET;ORAL | Prescription | No | AB | 207110 | WATSON LABS INC |
| BOSENTAN | BOSENTAN | 125MG | TABLET;ORAL | Prescription | No | AB | 207760 | ZYDUS PHARMS |
| TRACLEER | BOSENTAN | 125MG | TABLET;ORAL | Prescription | Yes | AB | 021290 | ACTELION |
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