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Application 211040
- Type
- ANDA
- Sponsor
- NOVITIUM PHARMA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SIROLIMUS | SIROLIMUS | SOLUTION;ORAL | 1MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 66689-347 | Sirolimus | Sirolimus | VistaPharm, Inc. | ANDA | Current |
| 66689-347 | Sirolimus | Sirolimus | VistaPharm, Inc. | ANDA | Current |
| 66689-347 | Sirolimus | Sirolimus | VistaPharm, Inc. | ANDA | Current |
| 66689-347 | Sirolimus | Sirolimus | VistaPharm, Inc. | ANDA | Current |
| 66689-347 | Sirolimus | Sirolimus | VistaPharm, Inc. | ANDA | Current |
| 66689-347 | Sirolimus | Sirolimus | VistaPharm, Inc. | ANDA | Current |
| 66689-347 | Sirolimus | Sirolimus | VistaPharm, Inc. | ANDA | Current |
| 66689-347 | Sirolimus | Sirolimus | VistaPharm, Inc. | ANDA | Current |
| 70954-075 | Sirolimus | Sirolimus | Novitium Pharma LLC | ANDA | Current |
| 70954-075 | Sirolimus | Sirolimus | Novitium Pharma LLC | ANDA | Current |
| 70954-075 | Sirolimus | Sirolimus | Novitium Pharma LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 57721 | ORIG | 2019-02-21 |