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    Setid B7b6e290 5168 46dc 9e7f 5995420ec1c1 Applno 203389 Form Capsule Delayed Release Oral Dosage Eq 75mg Base - Drug Product Composition: Cysteamine Bitartrate

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    Cysteamine Bitartrate

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    $ API Ref.Price (USD/KG) : 5Xls

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    USFDA APPLICATION NUMBER - 203389 / DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 75MG BASE

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CYSTEAMINE BITARTRATE(UNII: QO84GZ3TST)
    (CYSTEAMINE - UNII:5UX2SD1KE2)     		CYSTEAMINE75mg | 25mg

    Inactive Ingredients

    Ingredient Name
    Raptor Therapeutics Inc.
    FD&C BLUE NO. 2(L06K8R7DQK)
    GELATIN, UNSPECIFIED(2G86QN327L)
    HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
    MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
    SODIUM LAURYL SULFATE(368GB5141J)
    TALC(7SEV7J4R1U)
    TITANIUM DIOXIDE(15FIX9V2JP)
    TRIETHYL CITRATE(8Z96QXD6UM)
    WATER(059QF0KO0R)