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): 050168
Company: MONARCH PHARMS
| 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;5,000 UNITS/GM | OINTMENT;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 |
|---|---|---|---|---|---|---|---|
| 03/26/1957 | 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 |
|---|---|---|---|---|---|
| 11/21/2003 | SUPPL-78 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50168slr078_cotisporin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50168slr078ltr.pdf |
||
| 08/13/2001 | SUPPL-76 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1999 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/04/1998 | SUPPL-74 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/19/1999 | SUPPL-73 | Labeling |
Label is not available on this site. |
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| 03/26/1982 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/1981 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/19/1978 | SUPPL-67 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/06/1977 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/13/1977 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
| 06/16/1974 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/1974 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 02/12/1974 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1972 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1972 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 07/05/1972 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 06/23/1972 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 05/10/1971 | SUPPL-57 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/23/1973 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 07/24/1970 | SUPPL-55 | Labeling |
Label is not available on this site. |
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| 06/15/1970 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 05/25/1970 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 08/11/1970 | SUPPL-52 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/17/1970 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 04/07/1970 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 07/08/1969 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 03/04/1969 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/1968 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/02/1968 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 12/18/1967 | SUPPL-44 | Labeling |
Label is not available on this site. |
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| 08/11/1967 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 07/20/1967 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 07/20/1967 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 04/06/1967 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 03/03/1967 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 03/03/1967 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 02/24/1967 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 03/20/1967 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 02/10/1967 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 01/20/1967 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 01/13/1967 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 11/03/1966 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 08/26/1966 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 05/12/1966 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 06/08/1965 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 04/06/1965 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 03/22/1965 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 01/12/1965 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 01/11/1965 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 01/06/1965 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 12/22/1964 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 10/17/1963 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 10/04/1963 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 07/24/1963 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/01/1962 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/22/1993 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/24/1962 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/24/1962 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/07/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1986 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/04/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 09/06/1960 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/25/1984 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/06/1983 | SUPPL-1 | 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 |
|---|---|---|---|---|---|
| 11/21/2003 | SUPPL-78 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50168slr078_cotisporin_lbl.pdf |
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