CHIRHOSTIM از شرکت CHIRHOCLIN

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

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21256_humansecretin_lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21256ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-256_SyntheticHS.cfm

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

Label (PDF)

Letter (PDF)

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

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021256s004ltr.pdf

06/21/2007 SUPPL-2 Labeling

Label (PDF)

Letter (PDF)

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

Letter (PDF)

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
بخوانید  AMINOPHYLLINE از شرکت DURAMED PHARMS BARR
به بالای صفحه بردن