Skip to content
Application 203153
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TEMSIROLIMUS | TEMSIROLIMUS | SOLUTION;INTRAVENOUS | 25MG/ML (25MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16729-223 | Temsirolimus | temsirolimus | Accord Healthcare Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 55230 | ORIG | 2018-08-20 |