Details for New Drug Application (NDA): 216209
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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.
Pharmacology for NDA: 216209
Mechanism of Action | Melatonin Receptor Agonists |
Suppliers and Packaging for NDA: 216209
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RAMELTEON | ramelteon | TABLET;ORAL | 216209 | ANDA | Golden State Medical Supply, Inc. | 51407-523 | 51407-523-01 | 100 TABLET, FILM COATED in 1 BOTTLE (51407-523-01) |
RAMELTEON | ramelteon | TABLET;ORAL | 216209 | ANDA | Golden State Medical Supply, Inc. | 51407-523 | 51407-523-30 | 30 TABLET, FILM COATED in 1 BOTTLE (51407-523-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 8MG | ||||
Approval Date: | Nov 25, 2022 | TE: | AB | RLD: | No |
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