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    ANDA -- 219115 -- Chemistry, Manufacturing, and Controls (CMC) Review (Dexlansoprazole Delayed-Release Capsules)

    ANDA -- 219115 -- Chemistry, Manufacturing, and Controls (CMC) Review (Dexlansoprazole Delayed-Release Capsules)

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    This release contains the FDA's Chemistry, Manufacturing, and Controls (CMC) Review for ANDA 219115, covering Dexlansoprazole Delayed-Release Capsules, 30 mg and 60 mg, submitted by Alembic Pharmaceuticals Limited.

    Documents Delivered

    • Chemistry, Manufacturing, and Controls (CMC) Review
    • 44 pages of released records

    Portions of the records were redacted pursuant to FOIA Exemptions (b)(4) and (b)(6).

    Application: ANDA 219115
    Product: Dexlansoprazole Delayed-Release Capsules, 30 mg and 60 mg
    Sponsor: Alembic Pharmaceuticals Limited
    Approval Date: November 12, 2025
    Reference Product: Dexilant® (Dexlansoprazole)
    Document Type: FDA Bioequivalence Review
    Pages: 165
    Agency: U.S. Food and Drug Administration (FDA)
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