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    Approved Drug Products containing Misoprostol 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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    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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    Misoprostol

    ACTIVE PHARMA INGREDIENTS

    PRICE INFORMATION

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    01 2ACQ PHARMA

    02 2ACTAVIS LABS FL INC

    03 2AMNEAL PHARMS

    04 2ANI PHARMS

    05 2EXELA HOLDINGS

    06 4MICRO LABS

    07 2NOVEL LABS INC

    08 4PFIZER

    09 2SANDOZ

    10 2YUNG SHIN PHARM

    11 2ZYDUS PHARMS

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    01

    ANI PHARMS

    U.S.A
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    ANI PHARMS

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    RLD : No

    TE Code : AB

    MISOPROSTOL

    Brand Name : MISOPROSTOL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 0.1MG

    Approval Date : 2002-07-10

    Application Number : 76095

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    02

    ANI PHARMS

    U.S.A
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    RLD : No

    TE Code : AB

    MISOPROSTOL

    Brand Name : MISOPROSTOL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 0.2MG

    Approval Date : 2002-07-10

    Application Number : 76095

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    03

    NOVEL LABS INC

    U.S.A
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    NOVEL LABS INC

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    RLD : No

    TE Code :

    MISOPROSTOL

    Brand Name : MISOPROSTOL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 0.1MG

    Approval Date : 2012-07-25

    Application Number : 91667

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    NOVEL LABS INC

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    RLD : No

    TE Code :

    MISOPROSTOL

    Brand Name : MISOPROSTOL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 0.2MG

    Approval Date : 2012-07-25

    Application Number : 91667

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    05

    PFIZER

    U.S.A
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    PFIZER

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    RLD : Yes

    TE Code : AB

    MISOPROSTOL

    Brand Name : CYTOTEC

    Dosage Form : TABLET;ORAL

    Dosage Strength : 0.2MG

    Approval Date : 1988-12-27

    Application Number : 19268

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    06

    PFIZER

    U.S.A
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    PFIZER

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    RLD : Yes

    TE Code : AB

    MISOPROSTOL

    Brand Name : CYTOTEC

    Dosage Form : TABLET;ORAL

    Dosage Strength : 0.1MG

    Approval Date : 1990-09-21

    Application Number : 19268

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    07

    PFIZER

    U.S.A
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    PFIZER

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    RLD : Yes

    TE Code : AB

    DICLOFENAC SODIUM; MISOPROSTOL

    Brand Name : ARTHROTEC

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 50MG;0.2MG

    Approval Date : 1997-12-24

    Application Number : 20607

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    08

    PFIZER

    U.S.A
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    PFIZER

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    RLD : Yes

    TE Code : AB

    DICLOFENAC SODIUM; MISOPROSTOL

    Brand Name : ARTHROTEC

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 75MG;0.2MG

    Approval Date : 1997-12-24

    Application Number : 20607

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    09

    SANDOZ

    Switzerland
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    SANDOZ

    Switzerland
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    RLD : No

    TE Code :

    DICLOFENAC SODIUM; MISOPROSTOL

    Brand Name : DICLOFENAC SODIUM AND MISOPROSTOL

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 50MG;0.2MG

    Approval Date : 2013-05-09

    Application Number : 200158

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    10

    SANDOZ

    Switzerland
    Luxepack
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    SANDOZ

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    RLD : No

    TE Code :

    DICLOFENAC SODIUM; MISOPROSTOL

    Brand Name : DICLOFENAC SODIUM AND MISOPROSTOL

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 75MG;0.2MG

    Approval Date : 2013-05-09

    Application Number : 200158

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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