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
CORTEF از شرکت PHARMACIA AND UPJOHN
New Drug Application (NDA): 008697
Company: PHARMACIA AND UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORTEF | HYDROCORTISONE | 10MG | TABLET;ORAL | Prescription |
AB |
Yes | No |
| CORTEF | HYDROCORTISONE | 20MG | TABLET;ORAL | Prescription |
AB |
Yes | Yes |
| CORTEF | HYDROCORTISONE | 5MG | TABLET;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 12/15/1952 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
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 |
|---|---|---|---|---|---|
| 11/21/2019 | SUPPL-36 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/008697s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/008697Orig1s036ltr.pdf |
||
| 09/08/2016 | SUPPL-33 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008697s032_33lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008697Orig1s032,s033,009866Orig1s098,s105ltr.pdf |
||
| 09/08/2016 | SUPPL-32 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008697s032_33lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008697Orig1s032,s033,009866Orig1s098,s105ltr.pdf |
||
| 03/16/2001 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1993 | SUPPL-21 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/008697s021lbl.pdf |
||
| 12/08/1993 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/1983 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/1978 | SUPPL-14 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/21/2019 | SUPPL-36 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/008697s036lbl.pdf | |
| 09/08/2016 | SUPPL-33 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008697s032_33lbl.pdf | |
| 09/08/2016 | SUPPL-32 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008697s032_33lbl.pdf | |
| 12/28/1993 | SUPPL-21 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/008697s021lbl.pdf |
CORTEF
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CORTEF | HYDROCORTISONE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 008697 | PHARMACIA AND UPJOHN |
| HYDROCORTISONE | HYDROCORTISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 040646 | IMPAX LABS INC |
| HYDROCORTISONE | HYDROCORTISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 207029 | STRIDES PHARMA |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CORTEF | HYDROCORTISONE | 20MG | TABLET;ORAL | Prescription | Yes | AB | 008697 | PHARMACIA AND UPJOHN |
| HYDROCORTISONE | HYDROCORTISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 040646 | IMPAX LABS INC |
| HYDROCORTISONE | HYDROCORTISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 207029 | STRIDES PHARMA |
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CORTEF | HYDROCORTISONE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 008697 | PHARMACIA AND UPJOHN |
| HYDROCORTISONE | HYDROCORTISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 040646 | IMPAX LABS INC |
| HYDROCORTISONE | HYDROCORTISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 207029 | STRIDES PHARMA |
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