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 CASPER PHARMA LLC
New Drug Application (NDA): 050416
Company: CASPER PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORTISPORIN | BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | OINTMENT;OPHTHALMIC | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 05/10/1971 | 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 |
|---|---|---|---|---|---|
| 03/22/2004 | SUPPL-15 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50416slr015_cortisporin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50416slr015ltr.pdf |
||
| 04/19/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1998 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/13/1995 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/09/1995 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/22/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1993 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/23/1993 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/10/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/1994 | SUPPL-6 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/22/2004 | SUPPL-15 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50416slr015_cortisporin_lbl.pdf |
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