NDC 70482-076

OSMOLEX ER

Amantadine

OSMOLEX ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Adamas Pharma, Llc. The primary component is Amantadine Hydrochloride.

Product ID70482-076_8321bb20-293e-4848-b1be-3116bf9ca476
NDC70482-076
Product TypeHuman Prescription Drug
Proprietary NameOSMOLEX ER
Generic NameAmantadine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-06-01
Marketing CategoryNDA /
Application NumberNDA209410
Labeler NameAdamas Pharma, LLC
Substance NameAMANTADINE HYDROCHLORIDE
Active Ingredient Strength193 mg/1
Pharm ClassesInfluenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 70482-076-07

2 BLISTER PACK in 1 CARTON (70482-076-07) > 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2018-06-01
NDC Exclude FlagN
Sample Package?Y

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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