Details for New Drug Application (NDA): 211567
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The generic ingredient in RAMELTEON is ramelteon. There are three drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ramelteon profile page.
Summary for 211567
Tradename: | RAMELTEON |
Applicant: | Zydus Pharms |
Ingredient: | ramelteon |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211567
Mechanism of Action | Melatonin Receptor Agonists |
Suppliers and Packaging for NDA: 211567
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RAMELTEON | ramelteon | TABLET;ORAL | 211567 | ANDA | American Health Packaging | 60687-692 | 60687-692-65 | 50 BLISTER PACK in 1 CARTON (60687-692-65) / 1 TABLET in 1 BLISTER PACK (60687-692-11) |
RAMELTEON | ramelteon | TABLET;ORAL | 211567 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1344 | 70710-1344-1 | 100 TABLET in 1 BOTTLE (70710-1344-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 8MG | ||||
Approval Date: | Jul 22, 2019 | TE: | AB | RLD: | No |
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