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1. 5' Nor Anhydrovinblastine
2. 5'-nor-anhydrovinblastine
3. Kw 2307
4. Kw-2307
5. Kw2307
6. Navelbine
7. Vinorelbine
8. Vinorelbine Tartrate
1. Vinorelbine Tartrate
2. 125317-39-7
3. Kw 2307
4. Navelbine (tn)
5. Vinorelbine Ditartrate (jan)
6. Vinorelbine Bitartarate
7. Vinorelbine Tartrate (usp)
8. Schembl4334811
9. Schembl16766511
10. Amy22244
11. S4269
12. Akos037748842
13. Ccg-270632
14. As-75352
15. D01935
16. Bis((2r,3r)-2,3-dihydroxybutanedioic Acid); Methyl (1r,9r,10s,11r,12r,19r)-11-(acetyloxy)-12-ethyl-4-[(12s)-16-ethyl-12-(methoxycarbonyl)-1,10-diazatetracyclo[12.3.1.0(3),(1)(1).0?,?]octadeca-3(11),4,6,8,15-pentaen-12-yl]-10-hydroxy-5-methoxy-8-methyl-8,16-diazapentacyclo[10.6.1.0(1),?.0(2),?.0(1)?,(1)?]nonadeca-2(7),3,5,13-tetraene-10-carboxylate
| Molecular Weight | 1079.1 g/mol |
|---|---|
| Molecular Formula | C53H66N4O20 |
| Hydrogen Bond Donor Count | 10 |
| Hydrogen Bond Acceptor Count | 23 |
| Rotatable Bond Count | 16 |
| Exact Mass | 1078.42704051 g/mol |
| Monoisotopic Mass | 1078.42704051 g/mol |
| Topological Polar Surface Area | 364 Ų |
| Heavy Atom Count | 77 |
| Formal Charge | 0 |
| Complexity | 1820 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 11 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 3 |
| 1 of 2 | |
|---|---|
| Drug Name | Vinorelbine tartrate |
| Drug Label | Vinorelbine Tartrate Injection is for intravenous administration. Each vial contains vinorelbine tartrate equivalent to 10mg (1-mL vial) or 50 mg (5-mL vial) vinorelbine in Water for Injection, USP. No preservatives or other additives are present.... |
| Active Ingredient | Vinorelbine tartrate |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 10mg base/ml |
| Market Status | Prescription |
| Company | Bedford; Hospira; Jiangsu Hansoh Pharm; Teva Pharms Usa; Actavis Elizabeth; Fresenius Kabi Usa; Hikma Maple; Ebewe Pharma; Dr Reddys Labs |
| 2 of 2 | |
|---|---|
| Drug Name | Vinorelbine tartrate |
| Drug Label | Vinorelbine Tartrate Injection is for intravenous administration. Each vial contains vinorelbine tartrate equivalent to 10mg (1-mL vial) or 50 mg (5-mL vial) vinorelbine in Water for Injection, USP. No preservatives or other additives are present.... |
| Active Ingredient | Vinorelbine tartrate |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 10mg base/ml |
| Market Status | Prescription |
| Company | Bedford; Hospira; Jiangsu Hansoh Pharm; Teva Pharms Usa; Actavis Elizabeth; Fresenius Kabi Usa; Hikma Maple; Ebewe Pharma; Dr Reddys Labs |
Tubulin Modulators
Agents that interact with TUBULIN to inhibit or promote polymerization of MICROTUBULES. (See all compounds classified as Tubulin Modulators.)
Antineoplastic Agents, Phytogenic
Agents obtained from higher plants that have demonstrable cytostatic or antineoplastic activity. (See all compounds classified as Antineoplastic Agents, Phytogenic.)
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GDUFA
DMF Review : Reviewed
Rev. Date : 2016-04-23
Pay. Date : 2016-03-23
DMF Number : 14619
Submission : 1999-12-13
Status : Active
Type : II
Certificate Number : R1-CEP 2011-342 - Rev 00
Issue Date : 2018-08-06
Type : Chemical
Substance Number : 2107
Status : Valid
Registration Number : 303MF10150
Registrant's Address : Rue Fonds Jean Pa(^)ques, 8 1435 Mont-Saint-Guibert Belgium
Initial Date of Registration : 2021-09-17
Latest Date of Registration : --
NDC Package Code : 69910-0004
Start Marketing Date : 2015-06-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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GDUFA
DMF Review : Reviewed
Rev. Date : 2015-11-02
Pay. Date : 2015-06-11
DMF Number : 26091
Submission : 2013-12-30
Status : Active
Type : II
Certificate Number : CEP 2009-394 - Rev 06
Issue Date : 2024-04-11
Type : Chemical
Substance Number : 2107
Status : Valid
NDC Package Code : 62158-0001
Start Marketing Date : 2014-02-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9477
Submission : 1991-11-25
Status : Active
Type : II
Certificate Number : R1-CEP 2004-297 - Rev 05
Issue Date : 2020-02-25
Type : Chemical
Substance Number : 2107
Status : Valid
Registration Number : 218MF10576
Registrant's Address : 16 rue Jean Rostand ZI de Clergous 81600 GAILLAC FRANCE
Initial Date of Registration : 2006-06-15
Latest Date of Registration : --
Registrant Name : Bukwang Pharmaceutical Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-57-A-111-01
Manufacturer Name : Plantes & Industries - Pierre Fabre Medicament
Manufacturer Address : 16 rue Jean Rostand GAILLAC Cedex France
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9973
Submission : 1992-11-23
Status : Inactive
Type : II
Registrant Name : Bukwang Pharmaceutical Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-57-A-111-01
Manufacturer Name : Plantes & Industries - Pierre Fabre Medicament
Manufacturer Address : 16 rue Jean Rostand GAILLAC Cedex France
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USDMF
Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-23
Pay. Date : 2016-03-23
DMF Number : 14619
Submission : 1999-12-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23951
Submission : 2010-06-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20158
Submission : 2009-02-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16706
Submission : 2003-07-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19094
Submission : 2006-01-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16011
Submission : 2002-06-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9973
Submission : 1992-11-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9477
Submission : 1991-11-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21929
Submission : 2008-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15956
Submission : 2002-04-25
Status : Inactive
Type : II
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