Application 016750
- Type
- NDA
- Sponsor
- AMPHASTAR PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CORTROSYN | COSYNTROPIN | INJECTABLE;INJECTION | 0.25MG/VIAL | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0404-9839 | Cortrosyn | Cortrosyn | Henry Schein, Inc. | NDA | Current |
| 0404-9839 | Cortrosyn | Cortrosyn | Henry Schein, Inc. | NDA | Current |
| 0548-5900 | Cortrosyn | Cosyntropin | Amphastar Pharmaceuticals, Inc. | NDA | Current |
| 0548-5900 | Cortrosyn | Cosyntropin | Amphastar Pharmaceuticals, Inc. | NDA | Current |
| 50090-4547 | Cortrosyn | Cosyntropin | A-S Medication Solutions | NDA | Current |
| 52584-050 | Cortrosyn | Cortrosyn | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-050 | Cortrosyn | Cortrosyn | General Injectables & Vaccines, Inc | NDA | Current |
| 52584-050 | Cortrosyn | Cortrosyn | General Injectables & Vaccines, Inc | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 77154 | SUPPL | 2023-12-27 |
| 77128 | SUPPL | 2023-12-27 |
| 69579 | SUPPL | 2021-12-16 |
| 69578 | SUPPL | 2021-12-16 |
| 490 | SUPPL | 2002-11-08 |