You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 213815

✉ Email this page to a colleague

« Back to Dashboard

NDA 213815 describes RAMELTEON, which is a drug marketed by Actavis Labs Fl Inc, Andas 5 Holding, Appco, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Granules, I3 Pharms, Micro Labs, Xiromed, and Zydus Pharms, and is included in ten NDAs. It is available from twenty-five 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-six suppliers are listed for this compound. Additional details are available on the ramelteon profile page.

Summary for 213815

Tradename:	RAMELTEON
Applicant:	Appco
Ingredient:	ramelteon
Patents:	0

Pharmacology for NDA: 213815

Mechanism of Action	Melatonin Receptor Agonists

Suppliers and Packaging for NDA: 213815

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RAMELTEON	ramelteon	TABLET;ORAL	213815	ANDA	Upsher-Smith Laboratories, LLC	0832-1250	0832-1250-11	100 TABLET, FILM COATED in 1 BOTTLE (0832-1250-11)
RAMELTEON	ramelteon	TABLET;ORAL	213815	ANDA	Upsher-Smith Laboratories, LLC	0832-1250	0832-1250-30	30 TABLET, FILM COATED in 1 BOTTLE (0832-1250-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	8MG
Approval Date:	Oct 26, 2020	TE:	AB	RLD:	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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.