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
ACTIMMUNE از شرکت VIDARA THERAPEUTICS RESEARCH LTD
Biologic License Application (BLA): 103836
Company: VIDARA THERAPEUTICS RESEARCH LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACTIMMUNE | INTERFERON GAMMA-1B | 100UG/0.5ML | VIAL; SINGLE-USE | Prescription |
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 |
|---|---|---|---|---|---|---|---|
| 02/25/1999 | 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 |
|---|---|---|---|---|---|
| 08/27/2015 | SUPPL-5182 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103836s5182lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103836Orig1s5182ltr.pdf |
||
| 01/26/2007 | SUPPL-5098 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103836s5098LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103836s5098ltr.pdf |
||
| 09/13/2005 | SUPPL-5071 | Supplement |
Label is not available on this site. |
||
| 11/24/2004 | SUPPL-5050 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103836_5050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103836_5050ltr.pdf |
||
| 03/18/2004 | SUPPL-5033 | Supplement |
Label is not available on this site. |
||
| 05/09/2003 | SUPPL-5017 | Supplement |
Label is not available on this site. |
||
| 02/10/2000 | SUPPL-1001 | Supplement |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/inteint021000L.htm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/27/2015 | SUPPL-5182 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103836s5182lbl.pdf | |
| 01/26/2007 | SUPPL-5098 |
Supplement |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103836s5098LBL.pdf | |
| 11/24/2004 | SUPPL-5050 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103836_5050lbl.pdf |
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