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Also known as: Mls001401438, Chembl1895091, Hms2051p14, Hms2233m10, Ccg-101038, Nc00288
Molecular Formula
C23H30N2O9
Molecular Weight
478.5  g/mol
InChI Key
AXAGNMKWGBWLMO-GQMFVQBYSA-N

Formoterol Fumarate
1 2D Structure

Formoterol Fumarate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(E)-but-2-enedioic acid;N-[2-hydroxy-5-[(1S)-1-hydroxy-2-[[(2S)-1-(4-methoxyphenyl)propan-2-yl]amino]ethyl]phenyl]formamide;hydrate
2.1.2 InChI
InChI=1S/C19H24N2O4.C4H4O4.H2O/c1-13(9-14-3-6-16(25-2)7-4-14)20-11-19(24)15-5-8-18(23)17(10-15)21-12-22;5-3(6)1-2-4(7)8;/h3-8,10,12-13,19-20,23-24H,9,11H2,1-2H3,(H,21,22);1-2H,(H,5,6)(H,7,8);1H2/b;2-1+;/t13-,19+;;/m0../s1
2.1.3 InChI Key
AXAGNMKWGBWLMO-GQMFVQBYSA-N
2.1.4 Canonical SMILES
CC(CC1=CC=C(C=C1)OC)NCC(C2=CC(=C(C=C2)O)NC=O)O.C(=CC(=O)O)C(=O)O.O
2.1.5 Isomeric SMILES
C[C@@H](CC1=CC=C(C=C1)OC)NC[C@H](C2=CC(=C(C=C2)O)NC=O)O.C(=C/C(=O)O)\C(=O)O.O
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. Mls001401438

2. Chembl1895091

3. Hms2051p14

4. Hms2233m10

5. Ccg-101038

6. Nc00288

7. Smr000471620

2.3 Create Date
2007-12-08
3 Chemical and Physical Properties
Molecular Weight 478.5 g/mol
Molecular Formula C23H30N2O9
Hydrogen Bond Donor Count7
Hydrogen Bond Acceptor Count10
Rotatable Bond Count10
Exact Mass478.19513054 g/mol
Monoisotopic Mass478.19513054 g/mol
Topological Polar Surface Area166 Ų
Heavy Atom Count34
Formal Charge0
Complexity507
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3

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Farmabios Spa

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Virtual BoothAxplora- The partner of choice for complex APIs.

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Fermion Oy

Finland
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Astellas Pharma Inc

Japan

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Cipla Ltd

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Sicor Swiss Branch

Italy

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API Reference Price

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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"0.02","unit":"KGS","unitRateFc":"200000","totalValueFC":"4050.2","currency":"USD","unitRateINR":"16880000","date":"02-May-2024","totalValueINR":"337600","totalValueInUsd":"4050.2","indian_port":"Hyderabad Air","hs_no":"29242990","bill_no":"3306636","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"MANUEL POMBO ANGULO,28,3RD FLOOR 28050 MADRID SPAIN Madrid, , SpainSDNF Spain","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715625000,"product":"NOT MICRONIZED FORMOTEROL FUMARATE","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.06","actualQuantity":"60","unit":"GMS","unitRateFc":"110","totalValueFC":"6678.8","currency":"USD","unitRateINR":"9278.5","date":"14-May-2024","totalValueINR":"556710","totalValueInUsd":"6678.8","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29242970","bill_no":"1001749","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717525800,"product":"FORMOTEROL FUMARATE (BATCH NO.P-126M) (15 GMS) FORMOTEROL FUMARATE DIHYDRATE","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"0.015","unit":"KGS","unitRateFc":"176000","totalValueFC":"2925.3","currency":"EUR","unitRateINR":"16280000","date":"05-Jun-2024","totalValueINR":"244200","totalValueInUsd":"2925.3","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"3844348","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"AREA INDUSTRIAL DEL LIOBREGAT C\/ARGENT, 1 08755 CASTELBISBAL BARCELONASPAIN Barcelona, , Spain Spain","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718044200,"product":"FORMOTEROL FUMARATE (IUPAC NAME N-(2-HYDROXY-5-(1-HYDROXY-2-((1-(4-METHOXYPHENYL)PROPAN-2-YL)AMINO)ETHYL)PHENYL)FORMAMID","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"135000","totalValueFC":"272654","currency":"USD","unitRateINR":"11380500","date":"11-Jun-2024","totalValueINR":"22761000","totalValueInUsd":"272654","indian_port":"Indore-EPZ\/SEZ","hs_no":"29420090","bill_no":"1004147","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722191400,"product":"FORMOTEROL FUMARATE (IUPAC NAME N-(2-HYDROXY-5-(1-HYDROXY-2-((1-(4-METHOXYPHENYL)PROPAN-2-YL)AMINO)ETHYL)PHENYL)FORMAMID","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"135000","totalValueFC":"273097.3","currency":"USD","unitRateINR":"11414250","date":"29-Jul-2024","totalValueINR":"22828500","totalValueInUsd":"273097.3","indian_port":"Indore-EPZ\/SEZ","hs_no":"29420090","bill_no":"1005513","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722364200,"product":"FORMOTEROL FUMARATE","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"XXKE XXA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"0.27","actualQuantity":"266","unit":"GMS","unitRateFc":"148","totalValueFC":"39823.1","currency":"USD","unitRateINR":"12514.5","date":"31-Jul-2024","totalValueINR":"3328857","totalValueInUsd":"39823.1","indian_port":"Indore-EPZ\/SEZ","hs_no":"29242990","bill_no":"1005578","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"159, C.S.T. ROAD,"}]
04-Jan-2021
25-Oct-2024
KGS
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Average Price (USD/KGS)

Number of Transactions

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Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

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Drugs in Development

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Details:

The acquisition of “Combihale” is expected to strengthen Mankind’s presence in the inhalation respiratory market segment. Daffy is a soap-free moisturising bar for infant babies.


Lead Product(s): Formoterol Fumarate,Fluticasone Propionate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Combihale

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Mankind Pharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition February 16, 2022

Dr Reddy Company Banner

01

Antibody Engineering
Not Confirmed

Lead Product(s) : Formoterol Fumarate,Fluticasone Propionate

Therapeutic Area : Pulmonary/Respiratory Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Mankind Pharma

Deal Size : Undisclosed

Deal Type : Acquisition

Details : The acquisition of “Combihale” is expected to strengthen Mankind’s presence in the inhalation respiratory market segment. Daffy is a soap-free moisturising bar for infant babies.

Brand Name : Combihale

Molecule Type : Small molecule

Upfront Cash : Undisclosed

February 16, 2022

Dr Reddy Company Banner

Details:

Formoterol Fumarate is a long-acting bronchodilator used as a long-term treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema).


Lead Product(s): Formoterol Fumarate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Formoterol Fumarate-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 01, 2022

Aucta Company Banner

02

Lead Product(s) : Formoterol Fumarate

Therapeutic Area : Pulmonary/Respiratory Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Formoterol Fumarate is a long-acting bronchodilator used as a long-term treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchiti...

Brand Name : Formoterol Fumarate-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

December 01, 2022

Aucta Company Banner

Details:

Breztri Aerosphere is a combination of budesonide, glycopyrrolate and formoterol fumarate indicated for the maintenance treatment of patients with COPD.


Lead Product(s): Budesonide,Glycopyrronium Bromide,Formoterol Fumarate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Breztri Aerosphere

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 23, 2024

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03

AstraZeneca

United Kingdom
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Antibody Engineering
Not Confirmed

AstraZeneca

United Kingdom
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Antibody Engineering
Not Confirmed

Details : Breztri Aerosphere is a combination of budesonide, glycopyrrolate and formoterol fumarate indicated for the maintenance treatment of patients with COPD.

Brand Name : Breztri Aerosphere

Molecule Type : Small molecule

Upfront Cash : Not Applicable

November 23, 2024

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Details:

Two companies have a collaboration agreement to develop an environmentally friendly propellant for flutiform® (fluticasone propionate/formoterol fumarate) in a pMDI formulation.


Lead Product(s): Fluticasone Propionate,Formoterol Fumarate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Flutiform

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Vectura Ltd

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration April 16, 2024

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04

Mundipharma

Germany
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Antibody Engineering
Not Confirmed

Mundipharma

Germany
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Antibody Engineering
Not Confirmed

Details : Two companies have a collaboration agreement to develop an environmentally friendly propellant for flutiform® (fluticasone propionate/formoterol fumarate) in a pMDI formulation.

Brand Name : Flutiform

Molecule Type : Small molecule

Upfront Cash : Undisclosed

April 16, 2024

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Details:

Under the agreement, Mankind Pharma will distribute AstraZeneca's anti-asthma inhaled corticosteroid drug Symbicort, (budesonide/formoterol) approved to treat asthma and COPD, in India.


Lead Product(s): Budesonide,Formoterol Fumarate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Symbicort

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Mankind Pharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement March 13, 2024

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05

AstraZeneca

United Kingdom
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Antibody Engineering
Not Confirmed

AstraZeneca

United Kingdom
arrow
Antibody Engineering
Not Confirmed

Details : Under the agreement, Mankind Pharma will distribute AstraZeneca's anti-asthma inhaled corticosteroid drug Symbicort, (budesonide/formoterol) approved to treat asthma and COPD, in India.

Brand Name : Symbicort

Molecule Type : Small molecule

Upfront Cash : Undisclosed

March 13, 2024

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Details:

Breyna™ (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol is the first generic version of AstraZeneca's Symbicort drug-device combination product and is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).


Lead Product(s): Budesonide,Formoterol Fumarate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Breyna

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 31, 2023

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06

Viatris

U.S.A
arrow
Antibody Engineering
Not Confirmed

Viatris

U.S.A
arrow
Antibody Engineering
Not Confirmed

Details : Breyna™ (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol is the first generic version of AstraZeneca's Symbicort drug-device combination product and is indicated for certain patients with asthma or chronic obstructive pulmonary disease...

Brand Name : Breyna

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 31, 2023

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Details:

Duaklir (aclidinium bromide) and Duaklir (aclidinium bromide/formoterol) are inhaled respiratory medicines used for the maintenance treatment of COPD. Eklira is a LAMA and Duaklir is a combination therapy that contains both a LAMA and a long-acting beta2-agonist (LABA).


Lead Product(s): Aclidinium Bromide,Formoterol Fumarate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Duaklir

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 25, 2022

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07

Covis Pharma

Luxembourg
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Antibody Engineering
Not Confirmed

Covis Pharma

Luxembourg
arrow
Antibody Engineering
Not Confirmed

Details : Duaklir (aclidinium bromide) and Duaklir (aclidinium bromide/formoterol) are inhaled respiratory medicines used for the maintenance treatment of COPD. Eklira is a LAMA and Duaklir is a combination therapy that contains both a LAMA and a long-acting beta2...

Brand Name : Duaklir

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 25, 2022

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Details:

Luforbec (formoterol) oral inhalation is used to control wheezing, shortness of breath, and chest tightness caused by chronic obstructive pulmonary disease.


Lead Product(s): Formoterol Fumarate,Beclomethasone Dipropionate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Luforbec

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 25, 2022

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08

Lupin Ltd

India
arrow
Antibody Engineering
Not Confirmed

Lupin Ltd

India
arrow
Antibody Engineering
Not Confirmed

Details : Luforbec (formoterol) oral inhalation is used to control wheezing, shortness of breath, and chest tightness caused by chronic obstructive pulmonary disease.

Brand Name : Luforbec

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 25, 2022

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Details:

Breyna (Budesonide and Formoterol Fumarate Dihydrate), first approved generic version of AstraZeneca's Symbicort, a drug-device combination product, is indicated for certain patients with asthma or COPD and will be available in 160 /4.5 and 80/4.5 mcg dosage strengths.


Lead Product(s): Budesonide,Formoterol Fumarate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Breyna

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Kindeva Drug Delivery

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 16, 2022

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09

Viatris

U.S.A
arrow
Antibody Engineering
Not Confirmed

Viatris

U.S.A
arrow
Antibody Engineering
Not Confirmed

Details : Breyna (Budesonide and Formoterol Fumarate Dihydrate), first approved generic version of AstraZeneca's Symbicort, a drug-device combination product, is indicated for certain patients with asthma or COPD and will be available in 160 /4.5 and 80/4.5 mcg do...

Brand Name : Breyna

Molecule Type : Small molecule

Upfront Cash : Not Applicable

March 16, 2022

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Details:

U.S.FDA approved generic budesonide and formoterol fumarate dihydrate aerosol for treatment of two pulmonary health conditions: asthma in patients six years of age and older; and maintenance treatment of airflow obstruction and reducing exacerbations for patients with COPD.


Lead Product(s): Budesonide,Formoterol Fumarate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Budesonide/Formoterol Fumarate Dihydrate-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 15, 2022

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10

Viatris

U.S.A
arrow
Antibody Engineering
Not Confirmed

Viatris

U.S.A
arrow
Antibody Engineering
Not Confirmed

Details : U.S.FDA approved generic budesonide and formoterol fumarate dihydrate aerosol for treatment of two pulmonary health conditions: asthma in patients six years of age and older; and maintenance treatment of airflow obstruction and reducing exacerbations for...

Brand Name : Budesonide/Formoterol Fumarate Dihydrate-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

March 15, 2022

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - POWDER;INHALATION - 0.012MG/INH **Fe...DOSAGE - POWDER;INHALATION - 0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20831

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DOSAGE - POWDER, METERED;INHALATION - 0.4MG/I...DOSAGE - POWDER, METERED;INHALATION - 0.4MG/INH;0.012MG/INH

USFDA APPLICATION NUMBER - 210595

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DOSAGE - AEROSOL, METERED;INHALATION - 0.08MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.08MG/INH;0.0045MG/INH

USFDA APPLICATION NUMBER - 21929

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DOSAGE - AEROSOL, METERED;INHALATION - 0.16MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.16MG/INH;0.0045MG/INH

USFDA APPLICATION NUMBER - 21929

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DOSAGE - AEROSOL, METERED;INHALATION - 0.005M...DOSAGE - AEROSOL, METERED;INHALATION - 0.005MG/INH;0.05MG/INH

USFDA APPLICATION NUMBER - 22518

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DOSAGE - AEROSOL, METERED;INHALATION - 0.005M...DOSAGE - AEROSOL, METERED;INHALATION - 0.005MG/INH;0.1MG/INH

USFDA APPLICATION NUMBER - 22518

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DOSAGE - AEROSOL, METERED;INHALATION - 0.005M...DOSAGE - AEROSOL, METERED;INHALATION - 0.005MG/INH;0.2MG/INH

USFDA APPLICATION NUMBER - 22518

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