vinorelbine Injectable Solution
- Brand(s)
- Navelbine
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Pierre Fabre Pharmaceuticals, Inc. (2014-05-12)
- Oldest Current Product
- 2003-03-01
- License(s)
- NDA, ANDA
- RxNORM
- INJECTABLE SOLUTION\VINORELBINE
- FDAOB
- INJECTION\INJECTION\VINORELBINE TARTRATE\rdfq
INJECTION\INJECTION\VINORELBINE\rdfq - SPL Active
- INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\VINORELBINE TARTRATE
INTRAVENOUS\INJECTION, SOLUTION\VINORELBINE
INTRAVENOUS\INJECTION, SOLUTION\VINORELBINE TARTRATE
INTRAVENOUS\INJECTION\VINORELBINE TARTRATE - SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\VINORELBINE
INTRAVENOUS\INJECTION, SOLUTION\VINORELBINE
INTRAVENOUS\INJECTION\VINORELBINE
product(s) by strength(s)
vinorelbine 10 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 643700532 | Navelbine | NDA | Pierre Fabre Pharmaceuticals, Inc. | 2005-11-15 | VINORELBINE TARTRATE | INTRAVENOUS | INJECTION | NDA020388 | 6d47c96a-7fdc-48ac-9250-41c5d3ecf8db |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000690099 | ANDA | Pfizer Labs | 2012-09-01 | VINORELBINE TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA200148 | deac0e4c-91fd-40ac-b478-0236291af3c0 |
| 2 | 000690205 | ANDA | Pfizer Labs | 2012-09-01 | VINORELBINE TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA200148 | 831c2287-e7d1-41ff-90ed-1ddd38350590 |
| 3 | 007034182 | ANDA | Teva Parenteral Medicines, Inc | 2003-03-01 | VINORELBINE TARTRATE | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | ANDA076028 | fa49b48c-49ce-4a95-8d3f-70ca304926fb |
| 4 | 007034183 | ANDA | Teva Parenteral Medicines, Inc | 2003-03-01 | VINORELBINE TARTRATE | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | ANDA076028 | fa49b48c-49ce-4a95-8d3f-70ca304926fb |
| 5 | 250210204 | ANDA | Sagent Pharmaceuticals | 2014-09-15 | VINORELBINE TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA091106 | 10a70995-e04d-4044-b1dc-c9aa27460397 |
| 6 | 459630607 | ANDA | Actavis Inc. | 2009-09-14 | VINORELBINE | INTRAVENOUS | INJECTION, SOLUTION | ANDA078011 | dd3dcc9a-e40c-4677-9ee6-f318e7c7d835 |
| 7 | 617030341 | ANDA | Hospira Worldwide, Inc. | 2005-06-02 | VINORELBINE TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA076827 | 06eeaab8-a00d-4b41-b46b-40163f09ecb8 |
| 8 | 674570431 | ANDA | Mylan Institutional Llc | 2012-09-01 | VINORELBINE TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA200148 | 6a4d9c3b-1db8-4090-810c-3794b3ca59a4 |
| 9 | 674570481 | ANDA | Mylan Institutional Llc | 2012-09-01 | VINORELBINE TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA200148 | a37eb006-7c53-4f86-846c-955c5241b5f6 |
| 10 | 674570482 | ANDA | Mylan Institutional Llc | 2012-09-01 | VINORELBINE TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA200148 | a37eb006-7c53-4f86-846c-955c5241b5f6 |
invalid application product(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 667580045 | ANDA | Sandoz Inc | 2008-02-13 | VINORELBINE TARTRATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA078408 | 17badb0d-de35-40f4-8a9d-f03397de62ab |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA075992 | VINORELBINE TARTRATE | EUROHEALTH INTERNATIONAL SARL | 2003-06-10 | ANDA075992_001 | |
| 2 | ANDA076028 | VINORELBINE TARTRATE | TEVA PHARMACEUTICALS USA | 2003-02-03 | ANDA076028_001 | |
| 3 | ANDA076461 | VINORELBINE TARTRATE | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | 2003-12-11 | ANDA076461_001 | |
| 4 | ANDA076827 | VINORELBINE TARTRATE | HOSPIRA INC | 2005-06-02 | ANDA076827_001 | |
| 5 | ANDA076849 | VINORELBINE TARTRATE | FRESENIUS KABI USA LLC | 2005-04-18 | ANDA076849_001 | |
| 6 | ANDA078011 | VINORELBINE TARTRATE | ACTAVIS TOTOWA LLC | 2009-07-22 | ANDA078011_001 | |
| 7 | ANDA078408 | VINORELBINE TARTRATE | True | EBEWE PHARMA GES MBH NFG KG | 2008-02-13 | ANDA078408_001 |
| 8 | ANDA091106 | VINORELBINE TARTRATE | JIANGSU HANSOH PHARMACEUTICAL CO LTD | 2012-09-26 | ANDA091106_001 | |
| 9 | ANDA200148 | VINORELBINE | MYLAN LABORATORIES LTD | 2012-08-31 | ANDA200148_001 | |
| 10 | ANDA202017 | VINORELBINE TARTRATE | DR REDDYS LABORATORIES LTD | 2013-09-12 | ANDA202017_001 | |
| 11 | NDA020388 | NAVELBINE | PIERRE FABRE MEDICAMENT | 1994-12-23 | NDA020388_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA075992_001 | RX | VINORELBINE TARTRATE (EQ 10MG BASE/ML) | INJECTION | False | AP | 2003-06-10 | VINORELBINE TARTRATE |
| 2 | ANDA076028_001 | RX | VINORELBINE TARTRATE (EQ 10MG BASE/ML) | INJECTION | False | AP | 2003-02-03 | VINORELBINE TARTRATE |
| 3 | ANDA076461_001 | RX | VINORELBINE TARTRATE (EQ 10MG BASE/ML) | INJECTION | False | AP | 2003-12-11 | VINORELBINE TARTRATE |
| 4 | ANDA076827_001 | RX | VINORELBINE TARTRATE (EQ 10MG BASE/ML) | INJECTION | False | AP | 2005-06-02 | VINORELBINE TARTRATE |
| 5 | ANDA076849_001 | RX | VINORELBINE TARTRATE (EQ 10MG BASE/ML) | INJECTION | False | AP | 2005-04-18 | VINORELBINE TARTRATE |
| 6 | ANDA078011_001 | RX | VINORELBINE TARTRATE (EQ 10MG BASE/ML) | INJECTION | False | AP | 2009-07-22 | VINORELBINE TARTRATE |
| 7 | ANDA078408_001 | discontinued | VINORELBINE TARTRATE (EQ 10MG BASE/ML) | INJECTION | False | 2008-02-13 | VINORELBINE TARTRATE | |
| 8 | ANDA091106_001 | RX | VINORELBINE TARTRATE (EQ 10MG BASE/ML) | INJECTION | False | AP | 2012-09-26 | VINORELBINE TARTRATE |
| 9 | ANDA200148_001 | RX | VINORELBINE (EQ 10MG BASE/ML) | INJECTION | False | AP | 2012-08-31 | VINORELBINE |
| 10 | ANDA202017_001 | RX | VINORELBINE TARTRATE (EQ 10MG BASE/ML) | INJECTION | False | AP | 2013-09-12 | VINORELBINE TARTRATE |
| 11 | NDA020388_001 | RX | VINORELBINE TARTRATE (EQ 10MG BASE/ML) | INJECTION | True | AP | 1994-12-23 | NAVELBINE |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 06eeaab8-a00d-4b41-b46b-40163f09ecb8 (view SPL) | These highlights do not include all the information needed to use VINORELBINE TARTRATE INJECTION safely and effectively. See full prescribing information for VINORELBINE TARTRATE INJECTION.VINORELBINE TARTRATE INJECTION for intravenous useInitial U.S. Approval: 2005 | prescription | Human Prescription | Hospira Worldwide, Inc. | 2015-03-16 | 12 | 617030341 | |
| 2 | 10a70995-e04d-4044-b1dc-c9aa27460397 (view SPL) | These highlights do not include all the information needed to use Vinorelbine Injection, USP safely and effectively. See full prescribing information for Vinorelbine Injection, USP.Vinorelbine Injection, USP, for intravenous useInitial U.S. Approval: 1994 | prescription | Human Prescription | Sagent Pharmaceuticals | 2014-05-14 | 4 | 250210204 | |
| 3 | 17badb0d-de35-40f4-8a9d-f03397de62ab (view SPL) | Vinorelbine Injection USP | prescription | Human Prescription | Sandoz Inc | 2011-09-19 | 5 | 667580045 | |
| 4 | 6a4d9c3b-1db8-4090-810c-3794b3ca59a4 (view SPL) | These highlights do not include all the information needed to use Vinorelbine Injection, USP safely and effectively. See full prescribing information for Vinorelbine Injection, USP.VINORELBINE Injection, USP for intravenous use Initial U.S. Approval: 1994 | prescription | Human Prescription | Mylan Institutional Llc | 2014-05-29 | 2 | 674570431 | |
| 5 | 6d47c96a-7fdc-48ac-9250-41c5d3ecf8db (view SPL) | These highlights do not include all the information needed to use NAVELBINE safely and effectively. See full prescribing information for NAVELBINE. NAVELBINE (vinorelbine tartrate) injection, for intravenous use Initial U.S. Approval: 1994 | prescription | Human Prescription | Pierre Fabre Pharmaceuticals, Inc. | ANALYSIS, API MANUFACTURE, MANUFACTURE | 2014-05-12 | 13 | 643700532 |
| 6 | 831c2287-e7d1-41ff-90ed-1ddd38350590 (view SPL) | Vinorelbine Injection USP | prescription | Human Prescription | Pfizer Labs | 2013-03-08 | 1 | 000690205 | |
| 7 | a37eb006-7c53-4f86-846c-955c5241b5f6 (view SPL) | These highlights do not include all the information needed to use Vinorelbine Injection, USP safely and effectively. See full prescribing information for Vinorelbine Injection, USP. VINORELBINE Injection, USP for intravenous use Initial U.S. Approval: 1994 | prescription | Human Prescription | Mylan Institutional Llc | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | 2014-12-01 | 2 | 674570481, 674570482 |
| 8 | dd3dcc9a-e40c-4677-9ee6-f318e7c7d835 (view SPL) | These highlights do not include all the information needed to use vinorelbine injection safely and effectively. See full prescribing information for vinorelbine injection. VINORELBINE injection, USP, for intravenous use Initial U.S. Approval: 1994 | prescription | Human Prescription | Actavis Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-05-29 | 19 | 459630607 |
| 9 | deac0e4c-91fd-40ac-b478-0236291af3c0 (view SPL) | Vinorelbine Injection USP | prescription | Human Prescription | Pfizer Labs | 2012-07-18 | 1 | 000690099 | |
| 10 | fa49b48c-49ce-4a95-8d3f-70ca304926fb (view SPL) | These highlights do not include all the information needed to use vinorelbine injection USP safely and effectively. See full prescribing information for vinorelbine injection USP. VINORELBINE injection, for intravenous use Initial U.S. Approval: 1994 | prescription | Human Prescription | Teva Parenteral Medicines, Inc | 2015-09-10 | 6 | 007034182, 007034183 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII