NDC 68025-021

Osmolex ER

Amantadine

Osmolex ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Vertical Pharmaceuticals, Llc. The primary component is Amantadine.

Product ID68025-021_ce2e1a99-33cb-84e4-e053-2a95a90a71e6
NDC68025-021
Product TypeHuman Prescription Drug
Proprietary NameOsmolex ER
Generic NameAmantadine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2022-05-05
Marketing End Date2023-06-30
Marketing CategoryNDA /
Application NumberNDA209410
Labeler NameVertical Pharmaceuticals, LLC
Substance NameAMANTADINE
Active Ingredient Strength161 mg/1
Pharm ClassesInfluenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
NDC Exclude FlagN

Packaging

NDC 68025-021-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-021-30)
Marketing Start Date2022-05-05
Marketing End Date2023-06-30
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Osmolex ER" or generic name "Amantadine"

NDCBrand NameGeneric Name
68025-021Osmolex ERamantadine
68025-074Osmolex ERamantadine
68025-075Osmolex ERamantadine
68025-076Osmolex ERamantadine
68025-077Osmolex ERamantadine
70482-075OSMOLEX ERamantadine
70482-076OSMOLEX ERamantadine
46708-246amantadineamantadine
46708-586AmantadineAmantadine
60687-422AmantadineAmantadine
62332-246amantadineamantadine
62332-586AmantadineAmantadine
70482-085GOCOVRIAMANTADINE
70482-170GOCOVRIAMANTADINE

Trademark Results [Osmolex ER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OSMOLEX ER
OSMOLEX ER
87639712 5770506 Live/Registered
Osmotica Kereskedelmi és Szolgáltató Korlátolt Felelôsségû Társaság
2017-10-10

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