{"product_id":"anda-219115-bioequivalence-review-dexlansoprazole-delayed-release-capsules","title":"ANDA -- 219115 -- Bioequivalence Review (Dexlansoprazole Delayed-Release Capsules)","description":"\u003cp\u003eThis release contains the FDA's Bioequivalence Review for ANDA 219115, covering Dexlansoprazole Delayed-Release Capsules, 30 mg and 60 mg, submitted by Alembic Pharmaceuticals Limited.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDocuments Delivered\u003c\/strong\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eFDA Bioequivalence Review\u003c\/li\u003e\n\u003cli\u003e165 pages of released records\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003ePortions of the records were redacted pursuant to FOIA Exemptions (b)(4) and (b)(6).\u003c\/p\u003e\n\u003cp\u003e\u003cmeta charset=\"utf-8\"\u003e\u003cstrong\u003eApplication:\u003c\/strong\u003e ANDA 219115\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e Dexlansoprazole Delayed-Release Capsules, 30 mg and 60 mg\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e Alembic Pharmaceuticals Limited\u003cbr\u003e\u003cstrong\u003eApproval Date:\u003c\/strong\u003e November 12, 2025\u003cbr\u003e\u003cstrong\u003eReference Product:\u003c\/strong\u003e Dexilant® (Dexlansoprazole)\u003cbr\u003e\u003cstrong\u003eDocument Type:\u003c\/strong\u003e FDA Bioequivalence Review\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 165\u003cbr\u003e\u003cstrong\u003eAgency:\u003c\/strong\u003e U.S. Food and Drug Administration (FDA)\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51385925107876,"sku":"FDAANDA219115","price":376.89,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/anda-219115-bioequivalence-review-dexlansoprazole-delayed-release-capsules","provider":"FOIA Document Source","version":"1.0","type":"link"}