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
ABELCET از شرکت LEADIANT BIOSCI INC
New Drug Application (NDA): 050724
Company: LEADIANT BIOSCI INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ABELCET | AMPHOTERICIN B | 5MG/ML | INJECTABLE, LIPID COMPLEX;INJECTION | Prescription |
None |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/20/1995 | ORIG-1 | Approval |
Type 2 – New Active Ingredient |
PRIORITY |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/23/2013 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/2013 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1999 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/20/1999 | SUPPL-9 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/10/1999 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/11/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1996 | SUPPL-2 | Efficacy-New Indication |
Label is not available on this site. |
نظرات کاربران