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
CHIRHOSTIM از شرکت CHIRHOCLIN
New Drug Application (NDA): 021256
Company: CHIRHOCLIN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHIRHOSTIM | SECRETIN SYNTHETIC HUMAN | 16MCG/VIAL | FOR SOLUTION;INTRAVENOUS | Prescription |
None |
Yes | Yes |
| CHIRHOSTIM | SECRETIN SYNTHETIC HUMAN | 40MCG/VIAL | FOR SOLUTION;INTRAVENOUS | Prescription |
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 |
|---|---|---|---|---|---|---|---|
| 04/09/2004 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21256_humansecretin_lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/18/2017 | SUPPL-13 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021256s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021256Orig1s013ltr.pdf |
||
| 07/28/2015 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/21/2007 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021256s004ltr.pdf |
|
| 06/21/2007 | SUPPL-2 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021256s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021256s002ltr.pdf |
||
| 09/07/2004 | SUPPL-1 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21256s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/18/2017 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021256s013lbl.pdf | |
| 06/21/2007 | SUPPL-2 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021256s002lbl.pdf | |
| 04/09/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21256_humansecretin_lbl.pdf |
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