Ibandronate Injection
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Sun Pharmaceutical Industries Limited (2015-05-21)
- Oldest Current Product
- 2014-02-15
- License(s)
- ANDA
- RxNORM
- INJECTION\IBANDRONATE
- FDAOB
- INTRAVENOUS\INJECTION\IBANDRONATE SODIUM
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION\IBANDRONATE SODIUM
- SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION\IBANDRONIC ACID
product(s) by strength(s)
3 ml ibandronic acid 1 mg/ml injection
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 231550162 | ANDA | Heritage Pharmaceuticals Inc. | 2014-09-04 | IBANDRONATE SODIUM | INTRAVENOUS | INJECTION, SOLUTION | ANDA203987 | 9531b609-61df-4b77-be09-7469fc30ee2d |
| 2 | 627560218 | ANDA | Sun Pharmaceutical Industries Limited | 2014-02-15 | IBANDRONATE SODIUM | INTRAVENOUS | INJECTION, SOLUTION | ANDA090853 | be514be6-727a-4d6c-993b-52144f8e6de8 |
application(s)
| # | id | title | applicant | approved | patent | approved drug | in other drug docs |
|---|---|---|---|---|---|---|---|
| 1 | ANDA090853 | IBANDRONATE SODIUM | SUN PHARMACEUTICAL INDUSTRIES LTD | 2014-02-14 | ANDA090853_001 | Ibandronate Prefilled Syringe | |
| 2 | ANDA202235 | IBANDRONATE SODIUM | SAGENT PHARMACEUTICALS INC | 2014-09-02 | ANDA202235_001 | Ibandronate Prefilled Syringe | |
| 3 | ANDA202671 | IBANDRONATE SODIUM | MYLAN LABORATORIES LTD | 2014-09-02 | ANDA202671_001 | Ibandronate Prefilled Syringe | |
| 4 | ANDA203987 | IBANDRONATE SODIUM | EMCURE PHARMACEUTICALS LTD | 2014-09-02 | ANDA203987_001 | Ibandronate Prefilled Syringe | |
| 5 | ANDA204222 | IBANDRONATE SODIUM | APOTEX INC | 2015-10-16 | ANDA204222_001 | Ibandronate Prefilled Syringe | |
| 6 | ANDA205332 | IBANDRONATE SODIUM | AUROBINDO PHARMA LTD | 2015-08-19 | ANDA205332_001 | Ibandronate Prefilled Syringe | |
| 7 | NDA021858 | BONIVA | HOFFMANN LA ROCHE INC | 2006-01-06 | p5662918, SUBSTANCE | NDA021858_001 | Ibandronate Prefilled Syringe |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA090853_001 | RX | IBANDRONATE SODIUM (EQ 3MG BASE/3ML) | INTRAVENOUS | INJECTION | False | AP | 2014-02-14 | IBANDRONATE SODIUM |
| 2 | ANDA202235_001 | RX | IBANDRONATE SODIUM (EQ 3MG BASE/3ML) | INTRAVENOUS | INJECTION | False | AP | 2014-09-02 | IBANDRONATE SODIUM |
| 3 | ANDA202671_001 | RX | IBANDRONATE SODIUM (EQ 3MG BASE/3ML) | INTRAVENOUS | INJECTION | False | AP | 2014-09-02 | IBANDRONATE SODIUM |
| 4 | ANDA203987_001 | RX | IBANDRONATE SODIUM (EQ 3MG BASE/3ML) | INTRAVENOUS | INJECTION | False | AP | 2014-09-02 | IBANDRONATE SODIUM |
| 5 | ANDA204222_001 | RX | IBANDRONATE SODIUM (EQ 3MG BASE/3ML) | INTRAVENOUS | INJECTION | False | AP | 2015-10-16 | IBANDRONATE SODIUM |
| 6 | ANDA205332_001 | RX | IBANDRONATE SODIUM (EQ 3MG BASE/3ML) | INTRAVENOUS | INJECTION | False | AP | 2015-08-19 | IBANDRONATE SODIUM |
| 7 | NDA021858_001 | RX | IBANDRONATE SODIUM (EQ 3MG BASE/3ML) | INTRAVENOUS | INJECTION | True | AP | 2006-01-06 | BONIVA |
patent(s)
| # | id | expiration date | application(s) | in other drug docs |
|---|---|---|---|---|
| 1 | p5662918 (view patent) | 2014-09-02 | NDA021858 | Ibandronate Prefilled Syringe |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 9531b609-61df-4b77-be09-7469fc30ee2d (view SPL) | These highlights do not include all the information needed to use ibandronate sodium injection safely and effectively. See full prescribing information for ibandronate sodium injection. Ibandronate sodium injection, for intravenous use Initial U.S. Approval: 2003 | prescription | Human Prescription | Heritage Pharmaceuticals Inc. | analysis, label, manufacture, pack | 2015-07-02 | 7 | 231550162 |
| 2 | be514be6-727a-4d6c-993b-52144f8e6de8 (view SPL) | These highlights do not include all the information needed to use ibandronate sodium injection safely and effectively. See full prescribing information for ibandronate sodium injection. IBANDRONATE sodium injection, for intravenous use Initial U.S. Approval: 2003 | prescription | Human Prescription | Sun Pharmaceutical Industries Limited | ANALYSIS, MANUFACTURE | 2015-05-21 | 4 | 627560218 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII