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Application 200904
- Type
- ANDA
- Sponsor
- SANDOZ INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LINEZOLID | LINEZOLID | SOLUTION;INTRAVENOUS | 200MG/100ML (2MG/ML) | No | No |
| 002 | LINEZOLID | LINEZOLID | SOLUTION;INTRAVENOUS | 600MG/300ML (2MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0781-3431 | Linezolid | Linezolid | Sandoz Inc | ANDA | Current |
| 0781-3431 | Linezolid | Linezolid | Sandoz Inc | ANDA | Current |
| 0781-3431 | Linezolid | Linezolid | Sandoz Inc | ANDA | Current |
| 0781-3431 | Linezolid | Linezolid | Sandoz Inc | ANDA | Current |
| 0781-3431 | Linezolid | Linezolid | Sandoz Inc | ANDA | Current |
| 0781-3431 | Linezolid | Linezolid | Sandoz Inc | ANDA | Current |
| 0781-3431 | Linezolid | Linezolid | Sandoz Inc | ANDA | Current |
| 0781-3433 | Linezolid | Linezolid | Sandoz Inc | ANDA | Current |
| 0781-3433 | Linezolid | Linezolid | Sandoz Inc | ANDA | Current |
| 0781-3433 | Linezolid | Linezolid | Sandoz Inc | ANDA | Current |
| 0781-3433 | Linezolid | Linezolid | Sandoz Inc | ANDA | Current |
| 0781-3433 | Linezolid | Linezolid | Sandoz Inc | ANDA | Current |
| 0781-3433 | Linezolid | Linezolid | Sandoz Inc | ANDA | Current |
| 0781-3433 | Linezolid | Linezolid | Sandoz Inc | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 32071 | ORIG | 2015-07-20 |
| 9853 | ORIG | 2014-06-03 |