NDC 0169-1401

Macrilen

Macimorelin Acetate

Macrilen is a Oral Granule, For Solution in the Human Prescription Drug category. It is labeled and distributed by Novo Nordisk. The primary component is Macimorelin.

Product ID0169-1401_5f3f501c-3f74-44ba-bc9c-7a9ee78576b3
NDC0169-1401
Product TypeHuman Prescription Drug
Proprietary NameMacrilen
Generic NameMacimorelin Acetate
Dosage FormGranule, For Solution
Route of AdministrationORAL
Marketing Start Date2022-01-31
Marketing CategoryNDA /
Application NumberNDA205598
Labeler NameNovo Nordisk
Substance NameMACIMORELIN
Active Ingredient Strength60 mg/mg
Pharm ClassesGrowth Hormone Secretagogue Receptor Agonist [EPC], Growth Hormone Secretagogue Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0169-1401-01

1 POUCH in 1 CARTON (0169-1401-01) > 60 mg in 1 POUCH
Marketing Start Date2022-01-31
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Macrilen" or generic name "Macimorelin Acetate"

NDCBrand NameGeneric Name
0169-1401MacrilenMacimorelin acetate
71090-002MacrilenMacimorelin acetate

Trademark Results [Macrilen]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MACRILEN
MACRILEN
87978806 5624293 Live/Registered
AETERNA ZENTARIS GMBH
2017-09-08
MACRILEN
MACRILEN
87601284 not registered Live/Pending
AETERNA ZENTARIS GMBH
2017-09-08
MACRILEN
MACRILEN
87222769 5813944 Live/Registered
AEterna Zentaris GmbH
2016-11-01
MACRILEN
MACRILEN
86213980 not registered Dead/Abandoned
AETERNA ZENTARIS GMBH
2014-03-07
MACRILEN
MACRILEN
86213977 not registered Dead/Abandoned
AETERNA ZENTARIS GMBH
2014-03-07
MACRILEN
MACRILEN
86005271 not registered Dead/Abandoned
AEterna Zentaris GmbH
2013-07-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.