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Last Updated: November 11, 2024

Details for New Drug Application (NDA): 212650


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NDA 212650 describes RAMELTEON, which is a drug marketed by Actavis Labs Fl Inc, Andas 5 Holding, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Granules, I3 Pharms, Micro Labs, Upsher Smith Labs, Xiromed, and Zydus Pharms, and is included in ten NDAs. It is available from twenty-three suppliers. Additional details are available on the RAMELTEON profile page.

The generic ingredient in RAMELTEON is ramelteon. There are three drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ramelteon profile page.
Summary for 212650
Tradename:RAMELTEON
Applicant:I3 Pharms
Ingredient:ramelteon
Patents:0
Pharmacology for NDA: 212650
Mechanism of ActionMelatonin Receptor Agonists
Suppliers and Packaging for NDA: 212650
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAMELTEON ramelteon TABLET;ORAL 212650 ANDA TruPharma, LLC 52817-235 52817-235-10 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52817-235-10)
RAMELTEON ramelteon TABLET;ORAL 212650 ANDA TruPharma, LLC 52817-235 52817-235-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52817-235-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Apr 10, 2020TE:ABRLD:No

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