Application 021256
- Type
- NDA
- Sponsor
- CHIRHOCLIN
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021256-001 | CHIRHOSTIM | SECRETIN SYNTHETIC HUMAN | 16MCG/VIAL | FOR SOLUTION / INTRAVENOUS | RLD, RS | 2004-04-09 | |
| N021256-002 | CHIRHOSTIM | SECRETIN SYNTHETIC HUMAN | 40MCG/VIAL | FOR SOLUTION / INTRAVENOUS | RLD | 2007-06-21 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N021256-001 | CHIRHOSTIM | 16MCG/VIAL | FOR SOLUTION / INTRAVENOUS | RLD, RS | 2004-04-09 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021256-002 | CHIRHOSTIM | 40MCG/VIAL | FOR SOLUTION / INTRAVENOUS | RLD | 2007-06-21 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N021256-001 | CHIRHOSTIM | 16MCG/VIAL | FOR SOLUTION / INTRAVENOUS | RLD, RS | 2004-04-09 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | N021256-002 | CHIRHOSTIM | 40MCG/VIAL | FOR SOLUTION / INTRAVENOUS | RLD | 2007-06-21 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021256-001 | CHIRHOSTIM | 16MCG/VIAL | FOR SOLUTION / INTRAVENOUS | RLD, RS | 2004-04-09 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021256-002 | CHIRHOSTIM | 40MCG/VIAL | FOR SOLUTION / INTRAVENOUS | RLD | 2007-06-21 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021256-001 | CHIRHOSTIM | 16MCG/VIAL | FOR SOLUTION / INTRAVENOUS | RLD, RS | 2004-04-09 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021256-002 | CHIRHOSTIM | 40MCG/VIAL | FOR SOLUTION / INTRAVENOUS | RLD | 2007-06-21 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ChiRhoStim | HUMAN SECRETIN | ChiRhoClin, Inc. | b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd | 2025-10-08 | Warnings, Adverse reactions | 021256 NDA021256 67066-007 67066-005 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| 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 |