You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for New Drug Application (NDA): 212650


✉ Email this page to a colleague

« Back to Dashboard


NDA 212650 describes RAMELTEON, which is a drug marketed by Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Granules, I3 Pharms, Innogenix, Micro Labs, Upsher Smith Labs, Xiromed, and Zydus Pharms, and is included in ten NDAs. It is available from twenty-two 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-three 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
Formulation / Manufacturing:see details
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.