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
CORTENEMA از شرکت ANI PHARMS
New Drug Application (NDA): 016199
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORTENEMA | HYDROCORTISONE | 100MG/60ML | ENEMA;RECTAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 01/12/1966 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
PRIORITY |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/03/2014 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/2008 | SUPPL-35 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016199s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016199s035ltr.pdf |
||
| 09/25/1996 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/1995 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/29/1994 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/12/1992 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 12/28/1993 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/12/1992 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 03/24/1992 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/04/1984 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/1979 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/19/1978 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/29/1976 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 02/19/1979 | SUPPL-15 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/21/2008 | SUPPL-35 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016199s035lbl.pdf |
CORTENEMA
ENEMA;RECTAL; 100MG/60ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| COLOCORT | HYDROCORTISONE | 100MG/60ML | ENEMA;RECTAL | Prescription | No | AB | 075172 | CHARTWELL |
| CORTENEMA | HYDROCORTISONE | 100MG/60ML | ENEMA;RECTAL | Prescription | Yes | AB | 016199 | ANI PHARMS |
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