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    Approved Drug Products containing Tiotropium listed in the FDA Orange Book. Original Data : FDA Website

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    Bora Pharmaceuticals- Making success more certain.

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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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    Tiotropium

    ACTIVE PHARMA INGREDIENTS

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    01 5BOEHRINGER INGELHEIM

    02 1LUPIN

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    01

    BOEHRINGER INGELHEIM

    Germany
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    Not Confirmed
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    BOEHRINGER INGELHEIM

    Germany
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    RLD : Yes

    TE Code : AB

    TIOTROPIUM BROMIDE

    Brand Name : SPIRIVA

    Dosage Form : POWDER;INHALATION

    Dosage Strength : EQ 0.018MG BASE/INH

    Approval Date : 2004-01-30

    Application Number : 21395

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    02

    BOEHRINGER INGELHEIM

    Germany
    Luxepack
    Not Confirmed
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    BOEHRINGER INGELHEIM

    Germany
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    Not Confirmed
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    RLD : Yes

    TE Code :

    TIOTROPIUM BROMIDE

    Brand Name : SPIRIVA RESPIMAT

    Dosage Form : SPRAY, METERED;INHALATION

    Dosage Strength : EQ 0.0025MG BASE/INH

    Approval Date : 2014-09-24

    Application Number : 21936

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    03

    BOEHRINGER INGELHEIM

    Germany
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    BOEHRINGER INGELHEIM

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    RLD : Yes

    TE Code :

    TIOTROPIUM BROMIDE

    Brand Name : SPIRIVA RESPIMAT

    Dosage Form : SPRAY, METERED;INHALATION

    Dosage Strength : EQ 0.00125MG BASE/INH

    Approval Date : 2015-09-15

    Application Number : 21936

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    04

    BOEHRINGER INGELHEIM

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    RLD : Yes

    TE Code :

    OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

    Brand Name : STIOLTO RESPIMAT

    Dosage Form : SPRAY, METERED;INHALATION

    Dosage Strength : EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH

    Approval Date : 2015-05-21

    Application Number : 206756

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    BOEHRINGER INGELHEIM

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    RLD :

    TE Code :

    TIOTROPIUM BROMIDE

    Brand Name : SPIRIVA RESPIMAT

    Dosage Form : SPRAY;INHALATION

    Dosage Strength : 2.5MCG

    Approval Date :

    Application Number : 207070

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    06

    LUPIN

    India
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    LUPIN

    India
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    RLD : No

    TE Code : AB

    TIOTROPIUM BROMIDE

    Brand Name : TIOTROPIUM BROMIDE

    Dosage Form : POWDER;INHALATION

    Dosage Strength : EQ 0.018MG BASE/INH

    Approval Date : 2023-06-20

    Application Number : 211287

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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