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
ABIRATERONE ACETATE از شرکت AMNEAL PHARMS
Abbreviated New Drug Application (ANDA): 208327
Company: AMNEAL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription |
AB |
No | No |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 500MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/07/2019 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208327Orig1s000TAltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/20/2020 | SUPPL-10 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 11/04/2019 | SUPPL-3 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
ABIRATERONE ACETATE
TABLET;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | No | AB | 208327 | AMNEAL PHARMS |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | No | AB | 208453 | APOTEX |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | No | AB | 208416 | DR REDDYS LABS LTD |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | No | AB | 209227 | GLENMARK PHARMS |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | No | AB | 208339 | HIKMA |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | No | AB | 210686 | MSN |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | No | AB | 208446 | MYLAN |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | No | AB | 212462 | QILU |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | No | AB | 208371 | RISING |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | No | AB | 208432 | TEVA PHARMS USA |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | No | AB | 208380 | WOCKHARDT BIO AG |
| ZYTIGA | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | Yes | AB | 202379 | JANSSEN BIOTECH |
TABLET;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 500MG | TABLET;ORAL | Prescription | No | AB | 208327 | AMNEAL PHARMS |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 500MG | TABLET;ORAL | Prescription | No | AB | 208446 | MYLAN |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 500MG | TABLET;ORAL | Prescription | No | AB | 212462 | QILU |
| ZYTIGA | ABIRATERONE ACETATE | 500MG | TABLET;ORAL | Prescription | Yes | AB | 202379 | JANSSEN BIOTECH |
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