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
ADAGEN از شرکت LEADIANT BIOSCI INC
Biologic License Application (BLA): 019818
Company: LEADIANT BIOSCI INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADAGEN | PEGADEMASE BOVINE | 250 UNITS/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/21/1990 | ORIG-1 | Approval |
N/A; Orphan |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/21/2015 | SUPPL-56 | Supplement |
Label is not available on this site. |
||
| 07/17/2014 | SUPPL-55 | Supplement |
Label is not available on this site. |
||
| 06/05/2014 | SUPPL-53 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019818s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019818Orig1s053ltr.pdf |
||
| 03/04/2014 | SUPPL-52 | Supplement |
Label is not available on this site. |
||
| 12/17/2013 | SUPPL-51 | Supplement |
Label is not available on this site. |
||
| 01/10/2014 | SUPPL-50 | Supplement |
Label is not available on this site. |
||
| 10/15/2013 | SUPPL-48 | Supplement |
Label is not available on this site. |
||
| 10/07/2013 | SUPPL-47 | Supplement |
Label is not available on this site. |
||
| 01/15/2013 | SUPPL-46 | Supplement |
Label is not available on this site. |
||
| 09/25/2008 | SUPPL-42 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019818s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019818s042ltr.pdf |
||
| 10/26/2007 | SUPPL-34 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019818s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019818s034ltr.pdf |
||
| 04/15/2002 | SUPPL-24 | Supplement |
Label is not available on this site. |
||
| 08/17/2001 | SUPPL-23 | Supplement |
Label is not available on this site. |
||
| 09/16/1998 | SUPPL-17 | Supplement |
Label is not available on this site. |
||
| 12/06/1993 | SUPPL-14 | Supplement |
Label is not available on this site. |
||
| 06/16/1994 | SUPPL-13 | Supplement |
Label is not available on this site. |
||
| 08/11/1993 | SUPPL-11 | Supplement |
Label is not available on this site. |
||
| 11/10/1992 | SUPPL-9 | Supplement |
Label is not available on this site. |
||
| 12/28/1992 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
| 03/09/1993 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
| 04/22/1992 | SUPPL-5 | Supplement |
Label is not available on this site. |
||
| 04/13/1992 | SUPPL-4 | Supplement |
Label is not available on this site. |
||
| 09/27/1991 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
| 06/10/1991 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
| 11/28/1990 | SUPPL-1 | Supplement |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/05/2014 | SUPPL-53 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019818s053lbl.pdf | |
| 09/25/2008 | SUPPL-42 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019818s042lbl.pdf | |
| 10/26/2007 | SUPPL-34 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019818s034lbl.pdf |
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