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Chemistry

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Also known as: Amlodipine maleate, s-, 12ww9t2ita, Levamlodipine maleate [usan], 135969-53-8, Levamlodipine maleate (usan), Conjupri (tn)
Molecular Formula
C24H29ClN2O9
Molecular Weight
524.9  g/mol
InChI Key
TZNOWAJJWCGILX-HNUXRKMMSA-N
FDA UNII
12WW9T2ITA

Levamlodipine Maleate
1 2D Structure

Levamlodipine Maleate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(Z)-but-2-enedioic acid;3-O-ethyl 5-O-methyl (4S)-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
2.1.2 InChI
InChI=1S/C20H25ClN2O5.C4H4O4/c1-4-28-20(25)18-15(11-27-10-9-22)23-12(2)16(19(24)26-3)17(18)13-7-5-6-8-14(13)21;5-3(6)1-2-4(7)8/h5-8,17,23H,4,9-11,22H2,1-3H3;1-2H,(H,5,6)(H,7,8)/b;2-1-/t17-;/m0./s1
2.1.3 InChI Key
TZNOWAJJWCGILX-HNUXRKMMSA-N
2.1.4 Canonical SMILES
CCOC(=O)C1=C(NC(=C(C1C2=CC=CC=C2Cl)C(=O)OC)C)COCCN.C(=CC(=O)O)C(=O)O
2.1.5 Isomeric SMILES
CCOC(=O)C1=C(NC(=C([C@@H]1C2=CC=CC=C2Cl)C(=O)OC)C)COCCN.C(=C\C(=O)O)\C(=O)O
2.2 Other Identifiers
2.2.1 UNII
12WW9T2ITA
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Amlodipine Maleate, S-

2. 12ww9t2ita

3. Levamlodipine Maleate [usan]

4. 135969-53-8

5. Levamlodipine Maleate (usan)

6. Conjupri (tn)

7. Conjupri

8. Unii-12ww9t2ita

9. Schembl4732063

10. Chembl4594288

11. Levamlodipine Maleate [who-dd]

12. Levamlodipine Maleate [orange Book]

13. D11723

14. Q27251442

15. 3,5-pyridinedicarboxylic Acid, 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl Ester, (4s)-, (2z)-2-butenedioate (1:1)

16. 3-ethyl 5-methyl (4s)-2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate (2z)-but-2-enedioate

2.4 Create Date
2012-11-30
3 Chemical and Physical Properties
Molecular Weight 524.9 g/mol
Molecular Formula C24H29ClN2O9
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count11
Rotatable Bond Count12
Exact Mass524.1561582 g/mol
Monoisotopic Mass524.1561582 g/mol
Topological Polar Surface Area175 Ų
Heavy Atom Count36
Formal Charge0
Complexity766
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

FDF Dossiers

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American Pharma Summit
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LEVAMLODIPINE MALEATE

Brand Name : CONJUPRI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1.25MG BASE

Packaging :

Approval Date : 2019-12-19

Application Number : 212895

Regulatory Info : DISCN

Registration Country : USA

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02

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

LEVAMLODIPINE MALEATE

Brand Name : CONJUPRI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE

Packaging :

Approval Date : 2019-12-19

Application Number : 212895

Regulatory Info : DISCN

Registration Country : USA

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03

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

LEVAMLODIPINE MALEATE

Brand Name : CONJUPRI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Packaging :

Approval Date : 2019-12-19

Application Number : 212895

Regulatory Info : DISCN

Registration Country : USA

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FDA Orange Book

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01

CSPC OUYI

China
euroPLX 86 Munich
Not Confirmed
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CSPC OUYI

China
arrow
euroPLX 86 Munich
Not Confirmed

LEVAMLODIPINE MALEATE

Brand Name : CONJUPRI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1.25MG BASE

Approval Date : 2019-12-19

Application Number : 212895

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

blank

02

CSPC OUYI

China
euroPLX 86 Munich
Not Confirmed
arrow

CSPC OUYI

China
arrow
euroPLX 86 Munich
Not Confirmed

LEVAMLODIPINE MALEATE

Brand Name : CONJUPRI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE

Approval Date : 2019-12-19

Application Number : 212895

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

blank

03

CSPC OUYI

China
euroPLX 86 Munich
Not Confirmed
arrow

CSPC OUYI

China
arrow
euroPLX 86 Munich
Not Confirmed

LEVAMLODIPINE MALEATE

Brand Name : CONJUPRI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 2019-12-19

Application Number : 212895

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

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DOSAGE - TABLET;ORAL - EQ 1.25MG BASE

USFDA APPLICATION NUMBER - 212895

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DOSAGE - TABLET;ORAL - EQ 2.5MG BASE

USFDA APPLICATION NUMBER - 212895

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DOSAGE - TABLET;ORAL - EQ 5MG BASE

USFDA APPLICATION NUMBER - 212895

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