MedPath
FDA Product

Ramelteon

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Ramelteon

70771-1495

Regulatory Information

70771-1495

ANDA211567

C73584

September 27, 2023

USA

RAMELTEON TABLETS

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

918596198

Active Ingredients

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

RAMELTEON

Quantity: 8 mg in 1 1

Code: 901AS54I69

Class Code: ACTIB

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

HYPROMELLOSE 2910 (3 MPA.S)

Code: 0VUT3PMY82

Class Code: IACT

POLYETHYLENE GLYCOL 6000

Code: 30IQX730WE

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

SODIUM STEARYL FUMARATE

Code: 7CV7WJK4UI

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

RAMELTEON

Code: 901AS54I69

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