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    INACTIVE PHARMA INGREDIENTS

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    SUPPLIERS

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    Anmol Chemicals

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PEGS Boston Summit
    Not Confirmed
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    Anmol Chemicals

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39744

    Submission : 2024-03-27

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    FINISHED DOSAGE FORMULATIONS

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    FDF DOSSIERS SUPPLIERS

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    WATSON LABS INC

    EZETIMIBE; SIMVASTATIN

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    WATSON LABS INC
    Ireland
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    EZETIMIBE; SIMVASTATIN

    Drug : EZETIMIBE AND SIMVASTATIN

    Dosage Form : TABLET; ORAL

    Application Number : 202968

    Country : US

    Patented : No

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    ALKEM LABS LTD

    EZETIMIBE; SIMVASTATIN

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    ALKEM LABS LTD
    India
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    EZETIMIBE; SIMVASTATIN

    Drug : EZETIMIBE AND SIMVASTATIN

    Dosage Form : TABLET; ORAL

    Application Number : 209222

    Country : US

    Patented : No

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    AMNEAL PHARMS CO

    EZETIMIBE; SIMVASTATIN

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    AMNEAL PHARMS CO
    U.S.A
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    EZETIMIBE; SIMVASTATIN

    Drug : EZETIMIBE AND SIMVASTATIN

    Dosage Form : TABLET; ORAL

    Application Number : 208831

    Country : US

    Patented : No

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    ASTRAZENECA

    FELODIPINE

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    ASTRAZENECA
    United Kingdom
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    FELODIPINE

    Drug : PLENDIL

    Dosage Form : TABLET, EXTENDED RELEASE; ORAL

    Application Number : 19834

    Country : US

    Patented : No

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    AVERITAS

    NALOXEGOL OXALATE

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    AVERITAS
    U.S.A
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    NALOXEGOL OXALATE

    Drug : MOVANTIK

    Dosage Form : TABLET; ORAL

    Application Number : 204760

    Country : US

    Patented : Yes

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    VALEANT PHARMS NORTH

    PREDNICARBATE

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    VALEANT PHARMS NORTH
    Canada
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    PREDNICARBATE

    Drug : DERMATOP

    Dosage Form : OINTMENT; TOPICAL

    Application Number : 19568

    Country : US

    Patented : No

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    GALDERMA LABS LP

    DESONIDE

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    GALDERMA LABS LP
    U.S.A
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    DESONIDE

    Drug : DESOWEN

    Dosage Form : LOTION; TOPICAL

    Application Number : 72354

    Country : US

    Patented : No

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    GALDERMA LABS LP

    DESONIDE

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    GALDERMA LABS LP
    U.S.A
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    DESONIDE

    Drug : DESOWEN

    Dosage Form : CREAM; TOPICAL

    Application Number : 19048

    Country : US

    Patented : No

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    GENUS

    AMCINONIDE

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    GENUS
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    AMCINONIDE

    Drug : AMCINONIDE

    Dosage Form : OINTMENT; TOPICAL

    Application Number : 76096

    Country : US

    Patented : No

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    10

    HALEON US HOLDINGS

    IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE

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    PEGS Boston Summit
    Not Confirmed
    HALEON US HOLDINGS
    United Kingdom
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    Not Confirmed
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    IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE

    Drug : ADVIL CONGESTION RELIEF

    Dosage Form : TABLET; ORAL

    Application Number : 22565

    Country : US

    Patented : No

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    FDA Listed Dossiers

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    01

    Dosage Form : INJECTION

    PROPYL GALLATE
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    Not Confirmed

    Dosage Form : INJECTION

    USA
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    PROPYL GALLATE

    Route : INTRAMUSCULAR

    CAS : 121-79-9

    UNII : 8D4SNN7V92

    Potency Amount : 0

    Potency Unit : NA

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    Dosage Form : CAPSULE

    PROPYL GALLATE
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    Dosage Form : CAPSULE

    USA
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    PROPYL GALLATE

    Route : ORAL

    CAS : 121-79-9

    UNII : 8D4SNN7V92

    Potency Amount : 0.16

    Potency Unit : MG

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    03

    Dosage Form : CAPSULE, SOFT GELATIN

    PROPYL GALLATE
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    Not Confirmed

    Dosage Form : CAPSULE, SOFT GELATIN

    USA
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    Not Confirmed

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    PROPYL GALLATE

    Route : ORAL

    CAS : 121-79-9

    UNII : 8D4SNN7V92

    Potency Amount : 2

    Potency Unit : MG

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    Dosage Form : CONCENTRATE

    PROPYL GALLATE
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    Dosage Form : CONCENTRATE

    USA
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    Not Confirmed

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    PROPYL GALLATE

    Route : ORAL

    CAS : 121-79-9

    UNII : 8D4SNN7V92

    Potency Amount : 0.2

    Potency Unit : MG/1ML

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    Dosage Form : SUSPENSION, EXTENDED RELEASE

    PROPYL GALLATE
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    Not Confirmed

    Dosage Form : SUSPENSION, EXTENDED RELEASE

    USA
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    PEGS Boston Summit
    Not Confirmed

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    PROPYL GALLATE

    Route : ORAL

    CAS : 121-79-9

    UNII : 8D4SNN7V92

    Potency Amount : 1

    Potency Unit : MG/5ML

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    06

    Dosage Form : TABLET

    PROPYL GALLATE
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    Not Confirmed

    Dosage Form : TABLET

    USA
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    Not Confirmed

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    PROPYL GALLATE

    Route : ORAL

    CAS : 121-79-9

    UNII : 8D4SNN7V92

    Potency Amount : 1.36

    Potency Unit : MG

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    07

    Dosage Form : TABLET, EXTENDED RELEASE

    PROPYL GALLATE
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    Not Confirmed

    Dosage Form : TABLET, EXTENDED RELEASE

    USA
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    Not Confirmed

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    PROPYL GALLATE

    Route : ORAL

    CAS : 121-79-9

    UNII : 8D4SNN7V92

    Potency Amount : 0.067

    Potency Unit : MG

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    08

    Dosage Form : TABLET, FILM COATED

    PROPYL GALLATE
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    Not Confirmed

    Dosage Form : TABLET, FILM COATED

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    Not Confirmed

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    PROPYL GALLATE

    Route : ORAL

    CAS : 121-79-9

    UNII : 8D4SNN7V92

    Potency Amount : 0.04

    Potency Unit : MG

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    Dosage Form : TABLET, SUSTAINED ACTION

    PROPYL GALLATE
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    Dosage Form : TABLET, SUSTAINED ACTION

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    PROPYL GALLATE

    Route : ORAL

    CAS : 121-79-9

    UNII : 8D4SNN7V92

    Potency Amount : 0.06

    Potency Unit : MG

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    Dosage Form : TABLET, SUSTAINED ACTION, COAT...

    PROPYL GALLATE
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    Dosage Form : TABLET, SUSTAINED ACTION, COAT...

    USA
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    PROPYL GALLATE

    Route : ORAL

    CAS : 121-79-9

    UNII : 8D4SNN7V92

    Potency Amount : 0.04

    Potency Unit : MG

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    Sigma-Aldrich Corporation

    U.S.A
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    Propyl gallate

    CAS Number : 121-79-9

    Quantity Per Vial :

    Sale Unit :

    Price : $114.00

    Details :

    Monograph : PHR1118-1G

    Storage : +2°C to +30°C

    Code/Batch No :

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    Sigma-Aldrich Corporation

    U.S.A
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    Propyl Gallate Impurity A

    CAS Number :

    Quantity Per Vial :

    Sale Unit :

    Price : $593.00

    Details :

    Monograph : PHR2318-100MG

    Storage : +2°C to +30°C

    Code/Batch No :

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    C4 Therapeutics

    U.S.A
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    C4 Therapeutics

    U.S.A
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    Not Confirmed

    CAS Number :

    Quantity Per Vial :

    Sale Unit :

    Price : $114.00

    Details :

    Monograph : PHR1118-1G

    Storage : +2?C to +30?C

    Code/Batch No :

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    Country
    arrow
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    Country
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    Not Confirmed

    CAS Number :

    Quantity Per Vial :

    Sale Unit :

    Price : $593.00

    Details :

    Monograph : PHR2318-100MG

    Storage : +2?C to +30?C

    Code/Batch No :

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