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
CORTISPORIN از شرکت MONARCH PHARMS
New Drug Application (NDA): 050479
Company: MONARCH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORTISPORIN | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION/DROPS;OTIC | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 12/09/1975 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
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 |
|---|---|---|---|---|---|
| 05/28/2021 | SUPPL-20 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/28/1999 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1999 | SUPPL-15 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50479S015_Cortisporin.pdf |
|
| 03/15/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/04/1980 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/09/1979 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/18/1976 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 06/22/1976 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 01/29/1976 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/19/1987 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/01/1987 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/13/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/20/1984 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/06/1983 | SUPPL-1 | Labeling |
Label is not available on this site. |
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