Application 074848
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PROPOFOL | PROPOFOL | INJECTABLE;INJECTION | 10MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0641-6194 | Propofol | Propofol | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6194 | Propofol | Propofol | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6195 | Propofol | Propofol | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6195 | Propofol | Propofol | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6196 | Propofol | Propofol | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6196 | Propofol | Propofol | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 70518-3256 | Propofol | Propofol | REMEDYREPACK INC. | ANDA | Current |
| 72572-583 | Propofol | Propofol | Civica, Inc. | ANDA | Current |
| 72572-584 | Propofol | Propofol | Civica, Inc. | ANDA | Current |
| 72572-585 | Propofol | Propofol | Civica, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44248 | ORIG | 2007-06-18 |
| 8457 | ORIG | 2005-04-28 |