NDC 68025-076

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,. The primary component is Amantadine.

Product ID68025-076_1f4852ec-6fa2-4917-ade2-87b31560fd61
NDC68025-076
Product TypeHuman Prescription Drug
Proprietary NameOsmolex ER
Generic NameAmantadine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-06-01
Marketing CategoryNDA / NDA
Application NumberNDA209410
Labeler NameVertical Pharmaceuticals,
Substance NameAMANTADINE
Active Ingredient Strength193 mg/1
Pharm ClassesInfluenza A M2
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68025-076-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-076-30)
Marketing Start Date2018-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68025-076-14 [68025007614]

Osmolex ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA209410
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-22
Marketing End Date2019-10-25

NDC 68025-076-90 [68025007690]

Osmolex ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA209410
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-01

NDC 68025-076-11 [68025007611]

Osmolex ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA209410
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-01
Marketing End Date2018-05-14

NDC 68025-076-30 [68025007630]

Osmolex ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA209410
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-01

NDC 68025-076-07 [68025007607]

Osmolex ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA209410
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-25
Marketing End Date2019-10-25

Drug Details

Pharmacological Class

  • Influenza A M2 Protein Inhibitor [EPC]
  • M2 Protein Inhibitors [MoA]

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