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
CORTIFOAM از شرکت MYLAN SPECIALITY LP
New Drug Application (NDA): 017351
Company: MYLAN SPECIALITY LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORTIFOAM | HYDROCORTISONE ACETATE | 10% | AEROSOL, METERED;RECTAL | Prescription |
None |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/12/1982 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 10/03/2014 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/2003 | SUPPL-30 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17351slr030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017351_s030_CortifoamTOC.cfm |
|
| 11/20/2002 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/08/2002 | SUPPL-27 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17351slr027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/17-351s027_Cortifoam.cfm |
|
| 12/01/1999 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/1999 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/21/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1998 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/27/1996 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/27/1996 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/13/1997 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/1996 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/1995 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/02/1995 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/05/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1993 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/15/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 04/24/1986 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/20/1984 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/26/1983 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/30/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1982 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/06/1985 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/10/1982 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/10/1982 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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