FDA.reportPublic FDA data

RAMELTEON - Food and Drug Administration

Set ID
3a82c83c-9d80-697e-efb4-23e95bcb1bc2
Type
Indexing - Product Concept
Effective date
2024-08-09
Version
8
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameREMEDYREPACK INC.2026-09-01
RAMELTEON tablets, for oral use These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. Initial U.S. Approval: 2005Product nameAvPAK2026-05-27
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameAvPAK2026-05-20
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameBryant Ranch Prepack2026-05-07
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameASCLEMED USA INC. | ASCLEMED USA INC. DBA ENOVACHEM2026-05-07
These highlights do not include all the information needed to use ROZEREM ® safely and effectively. See full prescribing information for ROZEREM. ROZEREM (ramelteon) tablets, for oral use Initial U.S. Approval: 2005Product nameTakeda Pharmaceuticals America, Inc.2026-04-15
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameKanchan Healthcare Inc | Andas 5 holding llc | Innogenix, LLC.2026-04-01
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameBryant Ranch Prepack2026-03-19
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameMajor Pharmaceuticals2026-03-16
These highlights do not include all the information needed to use ROZEREM ® safely and effectively. See full prescribing information for ROZEREM. ROZEREM (ramelteon) tablets, for oral use Initial U.S. Approval: 2005Product nameTakeda Pharmaceuticals America, Inc.2026-03-06
RAMELTEON Tablets Rx Only These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS . Initial U.S. Approval: 2005Product nameAvKARE2026-01-15
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameUpsher-Smith Laboratories, LLC | Appco Pharma LLC2026-01-08
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameBryant Ranch Prepack2025-10-28
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameBryant Ranch Prepack2025-10-20
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameREMEDYREPACK INC.2025-09-30
Ramelteon Tablets Rx Only These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. Initial U.S. Approval: 2005Product nameAvPAK2025-07-23
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameMicro Labs Limited2025-04-23
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameProficient Rx LP2025-04-01
RamelteonProduct nameDirect_Rx2025-01-22
RamelteonProduct nameDirect_Rx2025-01-22
RAMELTEONProduct nameDIRECT RX2025-01-17
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2025-01-17
Ramelteon TabletsProduct nameAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31
Ramelteon TabletsProduct nameAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameBryant Ranch Prepack2024-12-19
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameQuality Care Products, LLC2024-12-18
RAMELTEON TABLETSProduct nameZydus Lifesciences Limited2024-12-04
Ramelteon tablets. These highlights do not include all the information needed to use Ramelteon tablets safely and effectively. See full prescribing information for Ramelteon tablets. Ramelteon tablets, for oral use Initial U.S. Approval: 2005Product nameGolden State Medical Supply, Inc.2024-09-20
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameAmerican Health Packaging2024-07-19
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameBryant Ranch Prepack2024-06-10
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameAurobindo Pharma Limited2024-05-17
RAMELTEON tablets These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS . RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameBryant Ranch Prepack2024-04-04
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameBryant Ranch Prepack2023-12-18
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameBryant Ranch Prepack2023-12-07
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2023-11-27
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameBryant Ranch Prepack2023-11-09
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameBryant Ranch Prepack2023-11-09
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2023-11-07
RAMELTEON tablets These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS . RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameGranules Pharmaceuticals Inc.2023-07-28
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product namei3 Pharmaceuticals, LLC | i3 Pharmceuticals, LLC2023-04-28
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameTruPharma, LLC | i3 Pharmceuticals, LLC2023-04-28
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameUpsher-Smith Laboratories, LLC2023-03-27
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameUnit Dose Services2022-10-17
These highlights do not include all the information needed to use Ramelteon tablets safely and effectively. See full prescribing information for Ramelteon tablets. Ramelteon tablets, for oral use Initial U.S. Approval: 2005Product nameXiromed, LLC | Xiromed Pharma Espana, S.L. | Chemo India Formulations Pvt Ltd2022-08-02
These highlights do not include all the information needed to use Ramelteon tablets safely and effectively. See full prescribing information for Ramelteon tablets. Ramelteon tablets, for oral use Initial U.S. Approval: 2005Product nameXiromed, LLC | Xiromed Pharma Espana, S.L. | Chemo India Formulations Pvt. Ltd. | Cerovene, Inc.2022-08-02
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS . RAMELTEON tablets, for oral use Initial U.S. Approval: 200 5Product nameBryant Ranch Prepack2022-04-29
RAMELTEON tablets These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS . RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameProficient Rx LP2022-04-01
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS . RAMELTEON tablets, for oral use Initial U.S. Approval: 200 5Product nameActavis Pharma, Inc.2022-03-01
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005Product nameDr.Reddys Laboratories Inc2021-12-08
These highlights do not include all the information needed to use ROZEREM safely and effectively. See full prescribing information for ROZEREM. ROZEREM (ramelteon) tablets Initial U.S. Approval: 2005Product nameCarilion Materials Management2017-12-28
These highlights do not include all the information needed to use ROZEREM safely and effectively. See full prescribing information for ROZEREM. ROZEREM (ramelteon) tablet, film coated for oral use Initial U.S. Approval: 2005Product nameRebel Distributors Corp2010-11-11
Physicians Total Care, Inc. human prescription drug labelProduct namePhysicians Total Care, Inc.2010-01-20