Last Updated: August 8, 2026

Details for New Drug Application (NDA): 215485

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NDA 215485 describes RAMELTEON, which is a drug marketed by Actavis Labs Fl Inc, Andas 5 Holding, Appco, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Granules, Hibrow Hlthcare, I3 Pharms, Micro Labs, Xiromed, and Zydus Pharms, and is included in eleven NDAs. It is available from twenty-seven 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-eight suppliers are listed for this compound. Additional details are available on the ramelteon profile page.

Summary for 215485

Tradename:	RAMELTEON
Applicant:	Hibrow Hlthcare
Ingredient:	ramelteon
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	8MG
Approval Date:	Jun 4, 2026	TE:	AB	RLD:	No

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