NDC 81583-100

ZTALMY

Ganaxolone

ZTALMY is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Marinus Pharmaceuticals, Inc.. The primary component is Ganaxolone.

Product ID81583-100_76fb746f-e81a-49b8-aac7-b80f7900c654
NDC81583-100
Product TypeHuman Prescription Drug
Proprietary NameZTALMY
Generic NameGanaxolone
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2022-06-06
Marketing CategoryNDA /
Application NumberNDA215904
Labeler NameMarinus Pharmaceuticals, Inc.
Substance NameGANAXOLONE
Active Ingredient Strength50 mg/mL
DEA ScheduleCV
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 81583-100-01

1 BOTTLE, PLASTIC in 1 CARTON (81583-100-01) > 110 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2022-06-06
NDC Exclude FlagN
Sample Package?N

Drug Details


Trademark Results [ZTALMY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZTALMY
ZTALMY
90046102 not registered Live/Pending
Marinus Pharmaceuticals, Inc.
2020-07-10

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