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    Approved Drug Products of Cheplapharm Arzneimittel Gmbh listed in the FDA Orange Book. Original Data : FDA Website

    EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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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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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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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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    Cheplapharm Arzneimittel Gmbh

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    01 2BUDESONIDE

    02 2CAPECITABINE

    03 5CLONAZEPAM

    04 1ETOPOSIDE PHOSPHATE

    05 1GANCICLOVIR SODIUM

    06 4HYDROXYUREA

    07 11OLANZAPINE

    08 3OLANZAPINE PAMOATE

    09 1ORLISTAT

    10 1TRETINOIN

    11 2VALGANCICLOVIR HYDROCHLORIDE

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    Brand Name : PULMICORT FLEXHALER

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    BUDESONIDE

    Cheplapharm Arzneimittel Gmbh

    Dosage Form : POWDER, METERED; INHALATION

    Proprietary Name : PULMICORT FLEXHALER

    Dosage Strength : 0.08MG/INH

    Approval Date : 2006-07-12

    Application Number : 21949

    RX/OTC/DISCN : RX

    RLD : Yes

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    RLD : Yes

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    BUDESONIDE

    Cheplapharm Arzneimittel Gmbh

    Dosage Form : POWDER, METERED; INHALATION

    Proprietary Name : PULMICORT FLEXHALER

    Dosage Strength : 0.16MG/INH

    Approval Date : 2006-07-12

    Application Number : 21949

    RX/OTC/DISCN : RX

    RLD : Yes

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    RLD : Yes

    TE Code : AB

    CAPECITABINE

    Cheplapharm Arzneimittel Gmbh

    Dosage Form : TABLET; ORAL

    Proprietary Name : XELODA

    Dosage Strength : 150MG

    Approval Date : 1998-04-30

    Application Number : 20896

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    CAPECITABINE

    Cheplapharm Arzneimittel Gmbh

    Dosage Form : TABLET; ORAL

    Proprietary Name : XELODA

    Dosage Strength : 500MG

    Approval Date : 1998-04-30

    Application Number : 20896

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    RLD : Yes

    TE Code : AB

    CLONAZEPAM

    Cheplapharm Arzneimittel Gmbh

    Dosage Form : TABLET; ORAL

    Proprietary Name : KLONOPIN

    Dosage Strength : 0.5MG

    Approval Date : 1982-01-01

    Application Number : 17533

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    RLD : Yes

    TE Code : AB

    CLONAZEPAM

    Cheplapharm Arzneimittel Gmbh

    Dosage Form : TABLET; ORAL

    Proprietary Name : KLONOPIN

    Dosage Strength : 1MG

    Approval Date : 1982-01-01

    Application Number : 17533

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    Brand Name : KLONOPIN

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    RLD : Yes

    TE Code : AB

    CLONAZEPAM

    Cheplapharm Arzneimittel Gmbh

    Dosage Form : TABLET; ORAL

    Proprietary Name : KLONOPIN

    Dosage Strength : 2MG

    Approval Date : 1982-01-01

    Application Number : 17533

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    Brand Name : KLONOPIN

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    RLD : No

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    CLONAZEPAM

    Cheplapharm Arzneimittel Gmbh

    Dosage Form : TABLET; ORAL

    Proprietary Name : KLONOPIN

    Dosage Strength : 0.125MG

    Approval Date : 1997-04-09

    Application Number : 17533

    RX/OTC/DISCN : DISCN

    RLD : No

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    Brand Name : KLONOPIN

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    TE Code :

    CLONAZEPAM

    Cheplapharm Arzneimittel Gmbh

    Dosage Form : TABLET; ORAL

    Proprietary Name : KLONOPIN

    Dosage Strength : 0.25MG

    Approval Date : 1997-04-09

    Application Number : 17533

    RX/OTC/DISCN : DISCN

    RLD : No

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    Brand Name : ETOPOPHOS PRESERVATI...

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    ETOPOSIDE PHOSPHATE

    Cheplapharm Arzneimittel Gmbh

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : ETOPOPHOS PRESERVATIVE F...

    Dosage Strength : EQ 100MG BASE/VIAL

    Approval Date : 1996-05-17

    Application Number : 20457

    RX/OTC/DISCN : RX

    RLD : Yes

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