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FDA Approval

Macrilen

CompanyNovo Nordisk (DUNS: 622920320)

Effective Date

January 30, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Macimorelin(60 mg in 1 mg)

Products (1)

Macrilen

NDC Product Code

0169-1401

Application Number

NDA205598

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 27, 2023

Ingredients

Silicon DioxideInactive

Code: ETJ7Z6XBU4Class: IACT

Sodium Stearyl FumarateInactive

Code: 7CV7WJK4UIClass: IACT

Saccharin SodiumInactive

Code: SB8ZUX40TYClass: IACT

CROSPOVIDONE, UNSPECIFIEDInactive

Code: 2S7830E561Class: IACT

MacimorelinActive

Code: 8680B21W73Class: ACTIBQuantity: 60 mg in 1 mg

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

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