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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 021782


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NDA 021782 describes ROZEREM, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. Additional details are available on the ROZEREM profile page.

The generic ingredient in ROZEREM is ramelteon. There are three drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ramelteon profile page.
Summary for 021782
Tradename:ROZEREM
Applicant:Takeda Pharms Usa
Ingredient:ramelteon
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021782
Mechanism of ActionMelatonin Receptor Agonists
Suppliers and Packaging for NDA: 021782
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROZEREM ramelteon TABLET;ORAL 021782 NDA Takeda Pharmaceuticals America, Inc. 64764-805 64764-805-10 100 TABLET, FILM COATED in 1 BOTTLE (64764-805-10)
ROZEREM ramelteon TABLET;ORAL 021782 NDA Takeda Pharmaceuticals America, Inc. 64764-805 64764-805-22 6 CARTON in 1 TRAY (64764-805-22) / 1 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Jul 22, 2005TE:ABRLD:Yes

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