Idarubicin Injectable Solution
- Brand(s)
- Idamycin
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Pharmacia And Upjohn Company (2015-01-06)
- Oldest Current Product
- 1997-02-17
- License(s)
- NDA, ANDA
- RxNORM
- INJECTABLE SOLUTION\IDARUBICIN
- FDAOB
- INJECTION\INJECTION\IDARUBICIN HYDROCHLORIDE\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION\IDARUBICIN HYDROCHLORIDE
INTRAVENOUS\INJECTION\IDARUBICIN HYDROCHLORIDE
INTRAVENOUS\SOLUTION\IDARUBICIN HYDROCHLORIDE - SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION\IDARUBICIN
INTRAVENOUS\INJECTION\IDARUBICIN
INTRAVENOUS\SOLUTION\IDARUBICIN
product(s) by strength(s)
idarubicin hydrochloride 1 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000132586 | Idamycin | NDA | Pharmacia And Upjohn Company | 1997-02-17 | IDARUBICIN HYDROCHLORIDE | INTRAVENOUS | SOLUTION | NDA050734 | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 |
| 2 | 000132596 | Idamycin | NDA | Pharmacia And Upjohn Company | 1997-02-17 | IDARUBICIN HYDROCHLORIDE | INTRAVENOUS | SOLUTION | NDA050734 | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 007034154 | ANDA | Teva Parenteral Medicines, Inc | 2002-10-01 | IDARUBICIN HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA065036 | d521b65f-3fd2-4efe-8cab-b444921dd223 |
| 2 | 007034155 | ANDA | Teva Parenteral Medicines, Inc | 2002-10-01 | IDARUBICIN HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA065036 | d521b65f-3fd2-4efe-8cab-b444921dd223 |
| 3 | 007034156 | ANDA | Teva Parenteral Medicines, Inc | 2002-10-01 | IDARUBICIN HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA065036 | d521b65f-3fd2-4efe-8cab-b444921dd223 |
| 4 | 531500336 | ANDA | Amneal-Agila, Llc | 2013-04-30 | IDARUBICIN HYDROCHLORIDE | INTRAVENOUS | INJECTION | ANDA200144 | 31c9691c-aa14-426d-b67f-f8d25e7200ce |
| 5 | 531500386 | ANDA | Amneal-Agila, Llc | 2013-04-30 | IDARUBICIN HYDROCHLORIDE | INTRAVENOUS | INJECTION | ANDA200144 | 31c9691c-aa14-426d-b67f-f8d25e7200ce |
| 6 | 531500411 | ANDA | Amneal-Agila, Llc | 2013-04-30 | IDARUBICIN HYDROCHLORIDE | INTRAVENOUS | INJECTION | ANDA200144 | 31c9691c-aa14-426d-b67f-f8d25e7200ce |
| 7 | 633230194 | ANDA | App Pharmaceuticals, Llc | 2009-08-11 | IDARUBICIN HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA065440 | e6b1716d-71ea-4e2b-996d-67ec40759672 |
invalid application product(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 667580055 | ANDA | Sandoz Inc | 2011-03-29 | IDARUBICIN HYDROCHLORIDE | INTRAVENOUS | INJECTION | ANDA091293 | 615d206a-b178-4ff4-b6c1-7e349099f3c7 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA065036 | IDARUBICIN HYDROCHLORIDE PFS | TEVA PHARMACEUTICALS USA | 2002-05-01 | ANDA065036_001 | |
| 2 | ANDA065037 | IDARUBICIN HYDROCHLORIDE | True | TEVA PARENTERAL MEDICINES INC | 2002-05-01 | ANDA065037_001, ANDA065037_002, ANDA065037_003 |
| 3 | ANDA065275 | IDARUBICIN HYDROCHLORIDE | EUROHEALTH INTERNATIONAL SARL | 2006-12-14 | ANDA065275_001 | |
| 4 | ANDA065288 | IDARUBICIN HYDROCHLORIDE | EUROHEALTH INTERNATIONAL SARL | 2007-05-15 | ANDA065288_001 | |
| 5 | ANDA065440 | IDARUBICIN HYDROCHLORIDE | FRESENIUS KABI USA LLC | 2009-08-04 | ANDA065440_001 | |
| 6 | ANDA091293 | IDARUBICIN HYDROCHLORIDE | True | SANDOZ INC | 2011-03-29 | ANDA091293_001 |
| 7 | ANDA200144 | IDARUBICIN HYDROCHLORIDE | MYLAN LABORATORIES LTD | 2012-10-11 | ANDA200144_001 | |
| 8 | NDA050661 | IDAMYCIN | True | PHARMACIA AND UPJOHN CO | 1990-09-27 | NDA050661_001, NDA050661_002, NDA050661_003 |
| 9 | NDA050734 | IDAMYCIN PFS | PHARMACIA AND UPJOHN CO | 1997-02-17 | NDA050734_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA065036_001 | RX | IDARUBICIN HYDROCHLORIDE (1MG/ML) | INJECTION | False | AP | 2002-05-01 | IDARUBICIN HYDROCHLORIDE PFS |
| 2 | ANDA065037_001 | discontinued | IDARUBICIN HYDROCHLORIDE (20MG/VIAL) | INJECTION | False | 2002-05-01 | IDARUBICIN HYDROCHLORIDE | |
| 3 | ANDA065037_002 | discontinued | IDARUBICIN HYDROCHLORIDE (10MG/VIAL) | INJECTION | False | 2002-05-01 | IDARUBICIN HYDROCHLORIDE | |
| 4 | ANDA065037_003 | discontinued | IDARUBICIN HYDROCHLORIDE (5MG/VIAL) | INJECTION | False | 2002-05-01 | IDARUBICIN HYDROCHLORIDE | |
| 5 | ANDA065275_001 | RX | IDARUBICIN HYDROCHLORIDE (1MG/ML) | INJECTION | False | AP | 2006-12-14 | IDARUBICIN HYDROCHLORIDE |
| 6 | ANDA065288_001 | RX | IDARUBICIN HYDROCHLORIDE (1MG/ML) | INJECTION | False | AP | 2007-05-15 | IDARUBICIN HYDROCHLORIDE |
| 7 | ANDA065440_001 | RX | IDARUBICIN HYDROCHLORIDE (1MG/ML) | INJECTION | False | AP | 2009-08-04 | IDARUBICIN HYDROCHLORIDE |
| 8 | ANDA091293_001 | discontinued | IDARUBICIN HYDROCHLORIDE (1MG/ML) | INJECTION | False | 2011-03-29 | IDARUBICIN HYDROCHLORIDE | |
| 9 | ANDA200144_001 | RX | IDARUBICIN HYDROCHLORIDE (1MG/ML) | INJECTION | False | AP | 2012-10-11 | IDARUBICIN HYDROCHLORIDE |
| 10 | NDA050661_001 | discontinued | IDARUBICIN HYDROCHLORIDE (10MG/VIAL) | INJECTION | False | 1990-09-27 | IDAMYCIN | |
| 11 | NDA050661_002 | discontinued | IDARUBICIN HYDROCHLORIDE (5MG/VIAL) | INJECTION | False | 1990-09-27 | IDAMYCIN | |
| 12 | NDA050661_003 | discontinued | IDARUBICIN HYDROCHLORIDE (20MG/VIAL) | INJECTION | False | 1995-04-25 | IDAMYCIN | |
| 13 | NDA050734_001 | RX | IDARUBICIN HYDROCHLORIDE (1MG/ML) | INJECTION | True | AP | 1997-02-17 | IDAMYCIN PFS |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 0a5a6d93-cc1e-4d7f-8da1-446c134503b3 (view SPL) | Idamycin PFS idarubicin hydrochloride injection | prescription | Human Prescription | Pharmacia And Upjohn Company | ANALYSIS, API MANUFACTURE, MANUFACTURE, PACK | 2015-01-06 | 6 | 000132586, 000132596, 000132576 |
| 2 | 31c9691c-aa14-426d-b67f-f8d25e7200ce (view SPL) | Idarubicin Hydrochloride Injection Rx only FOR INTRAVENOUS USE ONLY | prescription | Human Prescription | Amneal-Agila, Llc | ANALYSIS, MANUFACTURE, PACK, STERILIZE | 2012-12-28 | 1 | 531500336, 531500386, 531500411 |
| 3 | 615d206a-b178-4ff4-b6c1-7e349099f3c7 (view SPL) | Idarubicin Hydrochloride Injection | prescription | Human Prescription | Sandoz Inc | 2011-04-06 | 1 | 667580055 | |
| 4 | d521b65f-3fd2-4efe-8cab-b444921dd223 (view SPL) | IDArubicin Hydrochloride Injection | prescription | Human Prescription | Teva Parenteral Medicines, Inc | 2015-06-15 | 5 | 007034154, 007034155, 007034156 | |
| 5 | e6b1716d-71ea-4e2b-996d-67ec40759672 (view SPL) | Idarubicin Hydrochloride Injection, USP | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2015-08-10 | 2 | 633230194 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII