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): 050218
Company: MONARCH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORTISPORIN | HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | CREAM;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 04/16/1963 | 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 |
|---|---|---|---|---|---|
| 03/26/2013 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/2002 | SUPPL-51 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50218slr051ltr.pdf |
|
| 03/21/2001 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/13/2000 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1998 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/19/1999 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 04/27/1982 | SUPPL-45 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/26/1982 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1981 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/13/1977 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 05/01/1974 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 04/24/1974 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 03/08/1974 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 10/04/1972 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 07/27/1972 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 07/25/1972 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 06/21/1972 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 03/22/1972 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 05/11/1971 | SUPPL-33 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/26/1970 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 07/27/1970 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 08/11/1970 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1970 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/1969 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 04/25/1969 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 03/04/1969 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/1968 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 06/19/1967 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 05/15/1967 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 03/29/1967 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/20/1967 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 07/22/1966 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/30/1966 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/28/1965 | SUPPL-17 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/12/1965 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/15/1964 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/08/1964 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 05/08/1964 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/03/1964 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 09/04/1963 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 07/24/1963 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 07/17/1963 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/24/1963 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/23/1992 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/18/1987 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/04/1985 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/09/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/09/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
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