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Application 040323
- Type
- ANDA
- Sponsor
- VISTAPHARM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PREDNISOLONE | PREDNISOLONE | SYRUP;ORAL | 15MG/5ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 62135-250 | Prednisolone | Prednisolone oral | Chartwell RX, LLC | ANDA | Current |
| 62135-250 | Prednisolone | Prednisolone oral | Chartwell RX, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 29927 | ORIG | 1999-05-13 |
| 22125 | ORIG | 1999-05-13 |
| 17770 | ORIG | 1999-05-13 |