Composition
- Active ingredients
- RAMELTEON 8MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- RAMELTEON 8MG · TabletANDA091610-001 · Prescription
- RAMELTEON 8MG · TabletANDA211567-001 · Prescription
- RAMELTEON 8MG · TabletANDA213186-001 · Discontinued
- RAMELTEON 8MG · TabletANDA091693-001 · Prescription
- RAMELTEON 8MG · TabletANDA215435-001 · Prescription
- RAMELTEON 8MG · TabletANDA213815-001 · Prescription
- RAMELTEON 8MG · TabletANDA215972-001 · Prescription
- RAMELTEON 8MG · TabletANDA212650-001 · Prescription
- RAMELTEON 8MG · TabletThis page
- RAMELTEON 8MG · TabletANDA216209-001 · Prescription
- RAMELTEON 8MG · TabletANDA215243-001 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA215485.
At a glance
- Brand name
- Ramelteon
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Hibrow Hlthcare
- Status
- Prescription
- FDA approval
- 4 Jun 2026
- Application
- ANDA215485-001