Daunorubicin Injectable Solution
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Teva Parenteral Medicines, Inc (2012-12-20)
- Oldest Current Product
- 2004-04-01
- License(s)
- ANDA
- RxNORM
- INJECTABLE SOLUTION\DAUNORUBICIN
- FDAOB
- INJECTION\INJECTION\DAUNORUBICIN HYDROCHLORIDE\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION\DAUNORUBICIN HYDROCHLORIDE
- SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION\DAUNORUBICIN
product(s) by strength(s)
daunorubicin 5 mg/ml injectable solution
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 007035233 | ANDA | Teva Parenteral Medicines, Inc | 2004-04-01 | DAUNORUBICIN HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA065035 | 29fe455e-f177-4b0e-99fb-60a53016db72, 4b8a5ad9-9e34-4f88-997c-244d9a0ef2c2 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA061876 | CERUBIDINE | True | SANOFI AVENTIS US LLC | ANDA061876_001 | |
| 2 | ANDA064103 | CERUBIDINE | EUROHEALTH INTERNATIONAL SARL | 1995-02-03 | ANDA064103_001 | |
| 3 | ANDA064212 | DAUNORUBICIN HYDROCHLORIDE | True | TEVA PARENTERAL MEDICINES INC | 1998-06-23 | ANDA064212_001, ANDA064212_002 |
| 4 | ANDA065000 | DAUNORUBICIN HYDROCHLORIDE | FRESENIUS KABI USA LLC | 1999-05-25 | ANDA065000_001 | |
| 5 | ANDA065034 | DAUNORUBICIN HYDROCHLORIDE | FRESENIUS KABI USA LLC | 2001-11-20 | ANDA065034_001 | |
| 6 | ANDA065035 | DAUNORUBICIN HYDROCHLORIDE | TEVA PHARMACEUTICALS USA | 2000-01-24 | ANDA065035_001 | |
| 7 | NDA050484 | CERUBIDINE | True | WYETH AYERST RESEARCH | NDA050484_001 | |
| 8 | NDA050731 | DAUNORUBICIN HYDROCHLORIDE | EUROHEALTH INTERNATIONAL SARL | 1998-01-30 | NDA050731_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA061876_001 | discontinued | DAUNORUBICIN HYDROCHLORIDE (EQ 20MG BASE/VIAL) | INJECTION | False | CERUBIDINE | ||
| 2 | ANDA064103_001 | RX | DAUNORUBICIN HYDROCHLORIDE (EQ 20MG BASE/VIAL) | INJECTION | True | AP | 1995-02-03 | CERUBIDINE |
| 3 | ANDA064212_001 | discontinued | DAUNORUBICIN HYDROCHLORIDE (EQ 20MG BASE/VIAL) | INJECTION | False | 1998-06-23 | DAUNORUBICIN HYDROCHLORIDE | |
| 4 | ANDA064212_002 | discontinued | DAUNORUBICIN HYDROCHLORIDE (EQ 50MG BASE/VIAL) | INJECTION | False | 1999-05-03 | DAUNORUBICIN HYDROCHLORIDE | |
| 5 | ANDA065000_001 | RX | DAUNORUBICIN HYDROCHLORIDE (EQ 20MG BASE/VIAL) | INJECTION | False | AP | 1999-05-25 | DAUNORUBICIN HYDROCHLORIDE |
| 6 | ANDA065034_001 | RX | DAUNORUBICIN HYDROCHLORIDE (EQ 5MG BASE/VIAL) | INJECTION | False | 2001-11-20 | DAUNORUBICIN HYDROCHLORIDE | |
| 7 | ANDA065035_001 | RX | DAUNORUBICIN HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | False | AP | 2000-01-24 | DAUNORUBICIN HYDROCHLORIDE |
| 8 | NDA050484_001 | discontinued | DAUNORUBICIN HYDROCHLORIDE (EQ 20MG BASE/VIAL) | INJECTION | False | CERUBIDINE | ||
| 9 | NDA050731_001 | RX | DAUNORUBICIN HYDROCHLORIDE (EQ 5MG BASE/ML) | INJECTION | True | AP | 1998-01-30 | DAUNORUBICIN HYDROCHLORIDE |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | 29fe455e-f177-4b0e-99fb-60a53016db72 (view SPL) | DAUNORUBICIN Hydrochloride Injection | prescription | Human Prescription | Teva Parenteral Medicines, Inc | 2012-12-17 | 4 | 007035233 |
| 2 | 4b8a5ad9-9e34-4f88-997c-244d9a0ef2c2 (view SPL) | DAUNORUBICIN Hydrochloride Injection | prescription | Human Prescription | Teva Parenteral Medicines, Inc | 2012-12-20 | 1 | 007035233 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII