Skip to contentApplication 021256
- Type
- NDA
- Sponsor
- CHIRHOCLIN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CHIRHOSTIM | SECRETIN SYNTHETIC HUMAN | FOR SOLUTION;INTRAVENOUS | 16MCG/VIAL | Yes | Yes |
| 002 | CHIRHOSTIM | SECRETIN SYNTHETIC HUMAN | FOR SOLUTION;INTRAVENOUS | 40MCG/VIAL | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67066-005 | ChiRhoStim | Human Secretin | ChiRhoClin, Inc. | NDA | Current |
| 67066-005 | ChiRhoStim | Human Secretin | ChiRhoClin, Inc. | NDA | Current |
| 67066-005 | ChiRhoStim | Human Secretin | ChiRhoClin, Inc. | NDA | Current |
| 67066-007 | ChiRhoStim 40 | Human Secretin | ChiRhoClin, Inc. | NDA | Current |
| 67066-007 | ChiRhoStim 40 | Human Secretin | ChiRhoClin, Inc. | NDA | Current |
| 67066-007 | ChiRhoStim 40 | Human Secretin | ChiRhoClin, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 49032 | SUPPL | 2017-07-21 |
| 49017 | SUPPL | 2017-07-19 |
| 4801 | SUPPL | 2007-07-05 |
| 4800 | SUPPL | 2007-07-05 |
| 36481 | SUPPL | 2007-06-27 |
| 27232 | SUPPL | 2004-09-10 |
| 21552 | ORIG | 2004-08-09 |
| 14763 | ORIG | 2004-05-03 |
| 4799 | ORIG | 2004-04-20 |