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    Approved Drug Products containing Formoterol Fumarate Dihydrate listed in the FDA Orange Book. Original Data : FDA Website

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    Vamsi labs Formoterol Fumarate

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    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    Axplora- The partner of choice for complex APIs.

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    Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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    Formoterol Fumarate Dihydrate

    ACTIVE PHARMA INGREDIENTS

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    01 1ALEMBIC

    02 3ASTRAZENECA

    03 1ASTRAZENECA AB

    04 1COVIS

    05 1LUPIN

    06 1MANKIND PHARMA

    07 1MICRO LABS

    08 2MYLAN

    09 1MYLAN SPECLT

    10 3NOVARTIS

    11 3ORGANON LLC

    12 1RITEDOSE CORP

    13 1TEVA PHARMS USA INC

    14 1WILSHIRE PHARMS INC

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    01

    ASTRAZENECA

    United Kingdom
    Discovery on Target
    Not Confirmed
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    ASTRAZENECA

    United Kingdom
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    Discovery on Target
    Not Confirmed
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    RLD : Yes

    TE Code : AB

    BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

    Brand Name : SYMBICORT

    Dosage Form : AEROSOL, METERED;INHALATION

    Dosage Strength : 0.08MG/INH;0.0045MG/INH

    Approval Date : 2006-07-21

    Application Number : 21929

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    02

    ASTRAZENECA

    United Kingdom
    Discovery on Target
    Not Confirmed
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    ASTRAZENECA

    United Kingdom
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    Discovery on Target
    Not Confirmed
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    RLD : Yes

    TE Code : AB

    BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

    Brand Name : SYMBICORT

    Dosage Form : AEROSOL, METERED;INHALATION

    Dosage Strength : 0.16MG/INH;0.0045MG/INH

    Approval Date : 2006-07-21

    Application Number : 21929

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    03

    NOVARTIS

    Switzerland
    Discovery on Target
    Not Confirmed
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    NOVARTIS

    Switzerland
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    Discovery on Target
    Not Confirmed
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    RLD : Yes

    TE Code :

    FORMOTEROL FUMARATE

    Brand Name : FORADIL

    Dosage Form : POWDER;INHALATION

    Dosage Strength : 0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 2001-02-16

    Application Number : 20831

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    04

    NOVARTIS

    Switzerland
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    Not Confirmed
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    RLD :

    TE Code :

    FORMOTEROL FUMARATE

    Brand Name : FORADIL

    Dosage Form : POWDER; INHALATION

    Dosage Strength : 0.012MG/INH

    Approval Date :

    Application Number : 21279

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    05

    NOVARTIS

    Switzerland
    Discovery on Target
    Not Confirmed
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    NOVARTIS

    Switzerland
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    RLD : No

    TE Code :

    FORMOTEROL FUMARATE

    Brand Name : FORADIL CERTIHALER

    Dosage Form : POWDER;INHALATION

    Dosage Strength : 0.0085MG/INH

    Approval Date : 2006-12-15

    Application Number : 21592

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    06

    ORGANON LLC

    U.S.A
    Discovery on Target
    Not Confirmed
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    ORGANON LLC

    U.S.A
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    RLD : Yes

    TE Code :

    FORMOTEROL FUMARATE; MOMETASONE FUROATE

    Brand Name : DULERA

    Dosage Form : AEROSOL, METERED;INHALATION

    Dosage Strength : 0.005MG/INH;0.1MG/INH

    Approval Date : 2010-06-22

    Application Number : 22518

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    07

    ORGANON LLC

    U.S.A
    Discovery on Target
    Not Confirmed
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    ORGANON LLC

    U.S.A
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    Discovery on Target
    Not Confirmed
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    RLD : Yes

    TE Code :

    FORMOTEROL FUMARATE; MOMETASONE FUROATE

    Brand Name : DULERA

    Dosage Form : AEROSOL, METERED;INHALATION

    Dosage Strength : 0.005MG/INH;0.2MG/INH

    Approval Date : 2010-06-22

    Application Number : 22518

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    08

    ORGANON LLC

    U.S.A
    Discovery on Target
    Not Confirmed
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    ORGANON LLC

    U.S.A
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    Discovery on Target
    Not Confirmed
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    RLD : Yes

    TE Code :

    FORMOTEROL FUMARATE; MOMETASONE FUROATE

    Brand Name : DULERA

    Dosage Form : AEROSOL, METERED;INHALATION

    Dosage Strength : 0.005MG/INH;0.05MG/INH

    Approval Date : 2019-08-12

    Application Number : 22518

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    09

    TEVA PHARMS USA INC

    Israel
    Discovery on Target
    Not Confirmed
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    TEVA PHARMS USA INC

    Israel
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    Discovery on Target
    Not Confirmed
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    RLD : No

    TE Code : AN

    FORMOTEROL FUMARATE

    Brand Name : FORMOTEROL FUMARATE

    Dosage Form : SOLUTION;INHALATION

    Dosage Strength : 0.02MG/2ML

    Approval Date : 2021-06-22

    Application Number : 91141

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AN

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    10

    MYLAN SPECLT

    U.S.A
    Discovery on Target
    Not Confirmed
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    MYLAN SPECLT

    U.S.A
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    Discovery on Target
    Not Confirmed
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    RLD : Yes

    TE Code : AN

    FORMOTEROL FUMARATE

    Brand Name : PERFOROMIST

    Dosage Form : SOLUTION;INHALATION

    Dosage Strength : 0.02MG/2ML

    Approval Date : 2007-05-11

    Application Number : 22007

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AN

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