NDC 65757-652

LYBALVI

Olanzapine And Samidorphan L-malate

LYBALVI is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Alkermes, Inc.. The primary component is Olanzapine; Samidorphan L-malate.

Product ID65757-652_0e150f4e-3766-4ab0-8bb5-5f1224eada9c
NDC65757-652
Product TypeHuman Prescription Drug
Proprietary NameLYBALVI
Generic NameOlanzapine And Samidorphan L-malate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2021-09-20
Marketing CategoryNDA /
Application NumberNDA213378
Labeler NameAlkermes, Inc.
Substance NameOLANZAPINE; SAMIDORPHAN L-MALATE
Active Ingredient Strength10 mg/1; mg/1
Pharm ClassesAtypical Antipsychotic [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 65757-652-40

1 BOTTLE in 1 CARTON (65757-652-40) > 7 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2021-09-20
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "LYBALVI" or generic name "Olanzapine And Samidorphan L-malate"

NDCBrand NameGeneric Name
65757-651LYBALVIolanzapine and samidorphan L-malate
65757-652LYBALVIolanzapine and samidorphan L-malate
65757-653LYBALVIolanzapine and samidorphan L-malate
65757-654LYBALVIolanzapine and samidorphan L-malate

Trademark Results [LYBALVI]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LYBALVI
LYBALVI
90765843 not registered Live/Pending
Alkermes Pharma Ireland Limited
2021-06-10
LYBALVI
LYBALVI
90765835 not registered Live/Pending
Alkermes Pharma Ireland Limited
2021-06-10
LYBALVI
LYBALVI
90538254 not registered Live/Pending
Alkermes Pharma Ireland Limited
2021-02-22
LYBALVI
LYBALVI
88489837 not registered Live/Pending
Alkermes Pharma Ireland Limited
2019-06-26
LYBALVI
LYBALVI
87700839 not registered Live/Pending
Alkermes Pharma Ireland Limited
2017-11-29

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