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
AMICAR از شرکت AKORN
New Drug Application (NDA): 015229
Company: AKORN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMICAR | AMINOCAPROIC ACID | 250MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 06/08/1964 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 08/24/2004 | SUPPL-31 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197s040,15229s031,15230s031ltr.pdf |
|
| 04/03/2000 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 10/01/1999 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1997 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 03/07/1995 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/1994 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/19/1995 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 12/05/1983 | SUPPL-22 | Efficacy |
Label is not available on this site. |
||
| 06/06/1983 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 12/10/1982 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 09/22/1982 | SUPPL-19 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/03/1990 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 09/07/1979 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/10/1979 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/14/1977 | SUPPL-14 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/14/1977 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/14/1977 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/1977 | SUPPL-11 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
نظرات کاربران