Details for New Drug Application (NDA): 021782
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The generic ingredient in ROZEREM 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 021782
Tradename: | ROZEREM |
Applicant: | Takeda Pharms Usa |
Ingredient: | ramelteon |
Patents: | 0 |
Pharmacology for NDA: 021782
Mechanism of Action | Melatonin Receptor Agonists |
Suppliers and Packaging for NDA: 021782
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ROZEREM | ramelteon | TABLET;ORAL | 021782 | NDA | Takeda Pharmaceuticals America, Inc. | 64764-805 | 64764-805-10 | 100 TABLET, FILM COATED in 1 BOTTLE (64764-805-10) |
ROZEREM | ramelteon | TABLET;ORAL | 021782 | NDA | Takeda Pharmaceuticals America, Inc. | 64764-805 | 64764-805-22 | 6 CARTON in 1 TRAY (64764-805-22) / 1 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 8MG | ||||
Approval Date: | Jul 22, 2005 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021782
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | ROZEREM | ramelteon | TABLET;ORAL | 021782-001 | Jul 22, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | ROZEREM | ramelteon | TABLET;ORAL | 021782-001 | Jul 22, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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