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
AMINOHIPPURATE SODIUM از شرکت MERCK
New Drug Application (NDA): 005619
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMINOHIPPURATE SODIUM | AMINOHIPPURATE SODIUM | 20% | 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 |
|---|---|---|---|---|---|---|---|
| 12/30/1944 | ORIG-1 | Approval |
UNKNOWN |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/24/2013 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/2013 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/2011 | SUPPL-21 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005619s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/005619s021ltr.pdf |
||
| 06/03/2005 | SUPPL-20 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/005619s020ltr.pdf |
|
| 11/26/2002 | SUPPL-18 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/05619slr018ltr.pdf |
|
| 10/08/2002 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/30/2001 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/05619s16ltr.pdf |
|
| 11/02/1999 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 01/05/1998 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/11/1996 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/13/1987 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 09/01/1982 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/13/1987 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/13/1987 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/23/1981 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/08/1981 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1977 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 08/10/1973 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/10/1973 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/18/2011 | SUPPL-21 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005619s021lbl.pdf |
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