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
BRAVELLE از شرکت FERRING
Biologic License Application (BLA): 021289
Company: FERRING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRAVELLE | UROFOLLITROPIN | 75 IU/VIAL | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | Discontinued |
None |
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 |
|---|---|---|---|---|---|---|---|
| 05/06/2002 | ORIG-1 | Approval |
N/A |
|
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-289_Bravelle_prntlbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/27/2015 | SUPPL-27 | Supplement |
Label is not available on this site. |
||
| 07/27/2015 | SUPPL-26 | Supplement |
Label is not available on this site. |
||
| 09/10/2015 | SUPPL-25 | Supplement |
Label is not available on this site. |
||
| 07/18/2014 | SUPPL-22 | Supplement |
Label is not available on this site. |
||
| 07/11/2014 | SUPPL-21 | Supplement |
Label is not available on this site. |
||
| 02/19/2014 | SUPPL-19 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021289s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021289Orig1s019ltr.pdf |
||
| 11/14/2002 | SUPPL-2 | Supplement |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/19/2014 | SUPPL-19 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021289s019lbl.pdf | |
| 05/06/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-289_Bravelle_prntlbl.pdf |
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