Application 020491
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CORVERT | IBUTILIDE FUMARATE | INJECTABLE;INJECTION | 0.1MG/ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0009-3794 | Corvert | ibutilide fumarate | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-3794 | Corvert | ibutilide fumarate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-3794 | Corvert | ibutilide fumarate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-3794 | Corvert | ibutilide fumarate | Pharmacia and Upjohn Company LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 20682 | SUPPL | 2001-04-20 |
| 12634 | SUPPL | 2001-04-20 |
| 2599 | SUPPL | 2001-04-20 |
| 34708 | SUPPL | 1999-05-13 |
| 20680 | SUPPL | 1999-05-13 |
| 2598 | SUPPL | 1999-05-13 |
| 20681 | SUPPL | 1998-04-03 |
| 57463 | ORIG | 1996-03-16 |