Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021209
Company: CHIRHOCLIN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PORCINE SECRETIN PORCINE SECRETIN 16MCG INJECTABLE;SUBCUTANEOUS LYOPHILIZED POWER Prescription None No No
PORCINE SECRETIN PORCINE SECRETIN 40MCG INJECTABLE;SUBCUTANEOUS LYOPHILIZED POWER Prescription None No 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
04/04/2002 ORIG-1 Approval Type 6 - New Indication (no longer used) PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/26/2016 SUPPL-2 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021136s012s013,021209s002lbl.pdf
10/26/2016 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/26/2016 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021136s012s013,021209s002lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English