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
CERUMENEX از شرکت PHARM RES ASSOC
New Drug Application (NDA): 011340
Company: PHARM RES ASSOC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CERUMENEX | TROLAMINE POLYPEPTIDE OLEATE CONDENSATE | 10% | SOLUTION/DROPS;OTIC | 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 |
|---|---|---|---|---|---|---|---|
| 06/25/1958 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/17/2002 | SUPPL-16 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/11340s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11340s16ltr.pdf |
||
| 11/09/2000 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/2000 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/02/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/04/1981 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1977 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/17/2002 | SUPPL-16 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/11340s16lbl.pdf |
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