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    04 2Actavis Inc

    05 2Amneal Pharmaceuticals

    06 2Bial

    07 1Bioindustria L.I.M. Spa

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    Actavis Inc

    Ireland
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    DICLOFENAC SODIUM; MISOPROSTOL

    Brand Name : DICLOFENAC SODIUM AND MISOPROSTOL

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 50MG;0.2MG

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    Approval Date : 2012-07-09

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    02

    Actavis Inc

    Ireland
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    DICLOFENAC SODIUM; MISOPROSTOL

    Brand Name : DICLOFENAC SODIUM AND MISOPROSTOL

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 75MG;0.2MG

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    Approval Date : 2012-07-09

    Application Number : 201089

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    Registration Country : USA

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    03

    Amneal Pharmaceuticals

    U.S.A
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    DICLOFENAC SODIUM; MISOPROSTOL

    Brand Name : DICLOFENAC SODIUM AND MISOPROSTOL

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 50MG;0.2MG

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    Approval Date : 2016-11-25

    Application Number : 203995

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    Registration Country : USA

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    04

    Amneal Pharmaceuticals

    U.S.A
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    DICLOFENAC SODIUM; MISOPROSTOL

    Brand Name : DICLOFENAC SODIUM AND MISOPROSTOL

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 75MG;0.2MG

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    Approval Date : 2016-11-25

    Application Number : 203995

    Regulatory Info : RX

    Registration Country : USA

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    05

    ANI Pharmaceuticals Inc

    U.S.A
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    MISOPROSTOL

    Brand Name : MISOPROSTOL

    Dosage Form : TABLET;ORAL

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    Approval Date : 2002-07-10

    Application Number : 76095

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    06

    ANI Pharmaceuticals Inc

    U.S.A
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    Approval Date : 2002-07-10

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    Registration Country : USA

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    07

    Exela Pharma Sciences, LLC.

    U.S.A
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    DICLOFENAC SODIUM; MISOPROSTOL

    Brand Name : DICLOFENAC SODIUM AND MISOPROSTOL

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 50MG;0.2MG

    Packaging :

    Approval Date : 2014-03-14

    Application Number : 200540

    Regulatory Info : DISCN

    Registration Country : USA

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    08

    Exela Pharma Sciences, LLC.

    U.S.A
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    DICLOFENAC SODIUM; MISOPROSTOL

    Brand Name : DICLOFENAC SODIUM AND MISOPROSTOL

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 75MG;0.2MG

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    Approval Date : 2014-03-14

    Application Number : 200540

    Regulatory Info : DISCN

    Registration Country : USA

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    09

    Micro Labs Limited

    India
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    DICLOFENAC SODIUM; MISOPROSTOL

    Brand Name : DICLOFENAC SODIUM AND MISOPROSTOL

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 50MG;0.2MG

    Packaging :

    Approval Date : 2021-07-15

    Application Number : 204355

    Regulatory Info : RX

    Registration Country : USA

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    10

    Micro Labs Limited

    India
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    India
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    DICLOFENAC SODIUM; MISOPROSTOL

    Brand Name : DICLOFENAC SODIUM AND MISOPROSTOL

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 75MG;0.2MG

    Packaging :

    Approval Date : 2021-07-15

    Application Number : 204355

    Regulatory Info : RX

    Registration Country : USA

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    11

    Novel Laboratories, Inc.

    U.S.A
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    MISOPROSTOL

    Brand Name : MISOPROSTOL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 0.1MG

    Packaging :

    Approval Date : 2012-07-25

    Application Number : 91667

    Regulatory Info : DISCN

    Registration Country : USA

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    12

    Novel Laboratories, Inc.

    U.S.A
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    U.S.A
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    MISOPROSTOL

    Brand Name : MISOPROSTOL

    Dosage Form : TABLET;ORAL

    Dosage Strength : 0.2MG

    Packaging :

    Approval Date : 2012-07-25

    Application Number : 91667

    Regulatory Info : DISCN

    Registration Country : USA

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    13

    Pfizer Inc

    U.S.A
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    MISOPROSTOL

    Brand Name : CYTOTEC

    Dosage Form : TABLET;ORAL

    Dosage Strength : 0.2MG

    Packaging :

    Approval Date : 1988-12-27

    Application Number : 19268

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    Registration Country : USA

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    Pfizer Inc

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    Brand Name : CYTOTEC

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    Approval Date : 1990-09-21

    Application Number : 19268

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    Registration Country : USA

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    15

    Pfizer Inc

    U.S.A
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    Brand Name : ARTHROTEC

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 50MG;0.2MG

    Packaging :

    Approval Date : 1997-12-24

    Application Number : 20607

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    Registration Country : USA

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    16

    Pfizer Inc

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    DICLOFENAC SODIUM; MISOPROSTOL

    Brand Name : ARTHROTEC

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 75MG;0.2MG

    Packaging :

    Approval Date : 1997-12-24

    Application Number : 20607

    Regulatory Info : RX

    Registration Country : USA

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    17

    Sandoz B2B

    Switzerland
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    Switzerland
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    DICLOFENAC SODIUM; MISOPROSTOL

    Brand Name : DICLOFENAC SODIUM AND MISOPROSTOL

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 50MG;0.2MG

    Packaging :

    Approval Date : 2013-05-09

    Application Number : 200158

    Regulatory Info : DISCN

    Registration Country : USA

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    18

    Sandoz B2B

    Switzerland
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    DICLOFENAC SODIUM; MISOPROSTOL

    Brand Name : DICLOFENAC SODIUM AND MISOPROSTOL

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 75MG;0.2MG

    Packaging :

    Approval Date : 2013-05-09

    Application Number : 200158

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    Registration Country : USA

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    Yung Shin Pharm Industrial

    Taiwan
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    Brand Name : DICLOFENAC SODIUM AND MISOPROSTOL

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 50MG;0.2MG

    Packaging :

    Approval Date : 2020-02-19

    Application Number : 205143

    Regulatory Info : RX

    Registration Country : USA

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    Yung Shin Pharm Industrial

    Taiwan
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    DICLOFENAC SODIUM; MISOPROSTOL

    Brand Name : DICLOFENAC SODIUM AND MISOPROSTOL

    Dosage Form : TABLET, DELAYED RELEASE;ORAL

    Dosage Strength : 75MG;0.2MG

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    Approval Date : 2020-02-19

    Application Number : 205143

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