DEXLANSOPRAZOLE - Food and Drug Administration

Set ID
72065c97-63d2-e1f2-e507-59f0b1c78119
Type
Indexing - Product Concept
Effective date
2025-01-14
Version
5
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product nameGolden State Medical Supply, Inc.2026-06-17
These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product nameBryant Ranch Prepack2026-06-16
These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product nameUpsher-Smith Laboratories, LLC | TWi Pharmaceuticals, Inc. | Bora Pharmaceutical Laboratories Inc. Zhongli Plant | Apace Packaging LLC | BORA PHARMACEUTICAL LABORATORIES INC.2026-05-08
These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product nameUpsher-Smith Laboratories, LLC | TWi Pharmaceuticals, Inc. | Bora Pharmaceutical Laboratories Inc. Zhongli Plant | Apace Packaging LLC | BORA PHARMACEUTICAL LABORATORIES INC.2026-05-04
DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product nameGolden State Medical Supply, Inc.2026-04-16
These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product namePar Health USA, LLC2026-04-13
These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product nameUpsher-Smith Laboratories, LLC | TWi Pharmaceuticals, Inc. | Bora Pharmaceutical Laboratories Inc. Zhongli Plant | Apace Packaging LLC | BORA PHARMACEUTICAL LABORATORIES INC.2026-03-20
DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product nameGolden State Medical Supply, Inc.2026-02-24
These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product nameBryant Ranch Prepack2026-02-09
These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product nameAlembic Pharmaceuticals Limited | Alembic Pharmaceuticals Limited (Formulation Division-IV)2025-11-19
These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product nameAlembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited (Formulation Division-IV)2025-11-14
These highlights do not include all the information needed to use DEXILANT ® safely and effectively. See full prescribing information for DEXILANT. DEXILANT (dexlansoprazole) delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product nameTakeda Pharmaceuticals America, Inc. | Takeda Ireland Limited | Takeda GmbH2025-02-17
These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product nameA-S Medication Solutions2024-11-13
These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product nameBryant Ranch Prepack2024-11-04
These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product nameBryant Ranch Prepack2024-01-29
These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product nameBryant Ranch Prepack2024-01-05
These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product nameA-S Medication Solutions2023-11-22
These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product nameTWI PHARMACEUTICALS, INC. | Takeda Pharmaceutical Company Limited | Abbvie Inc | Catalent Pharma Solutions, LLC | Takeda GmbH | Takeda Ireland Limited | Patheon Manufacturing Services LLC | Anderson Brecon Inc | F.I.S. FABBRICA ITALIANA SINTETICI S.P.A.2023-08-03
These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES . DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product nameMylan Pharmaceuticals Inc.2023-07-15
These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES. DEXLANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product nameA-S Medication Solutions2023-06-06
These highlights do not include all the information needed to use DEXILANT safely and effectively. See full prescribing information for DEXILANT. DEXILANT (dexlansoprazole) delayed-release capsules, for oral use Initial U.S. Approval: 1995 (lansoprazole)Product namePhysicians Total Care, Inc.2012-02-08
Physicians Total Care, Inc. human prescription drug labelProduct namePhysicians Total Care, Inc.2010-01-11