Details for New Drug Application (NDA): 213815
✉ Email this page to a colleague
NDA 213815 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.
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 213815
| Tradename: | RAMELTEON |
| Applicant: | Upsher Smith Labs |
| 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
