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Generated: January 23, 2019

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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 four suppliers. There are two patents protecting this drug and one Paragraph IV challenge. 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. Four 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:2
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 Rebel Distributors Corp 21695-183 21695-183-30 30 TABLET, FILM COATED in 1 BOTTLE (21695-183-30)
ROZEREM ramelteon TABLET;ORAL 021782 NDA Bryant Ranch Prepack 63629-3389 63629-3389-1 30 TABLET, FILM COATED in 1 BOTTLE (63629-3389-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Jul 22, 2005TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Nov 16, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING A BIOLOGICAL RHYTHM DISORDER, SUCH AS INSOMNIA
Patent:➤ Try a Free TrialPatent Expiration:Jul 22, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET

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