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Last Updated: July 4, 2020

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Details for New Drug Application (NDA): 209410


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NDA 209410 describes OSMOLEX ER, which is a drug marketed by Osmotica Pharm and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the OSMOLEX ER profile page.

The generic ingredient in OSMOLEX ER is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
Summary for 209410
Tradename:OSMOLEX ER
Applicant:Osmotica Pharm
Ingredient:amantadine hydrochloride
Patents:8
Formulation / Manufacturing:see details
Pharmacology for NDA: 209410
Mechanism of ActionM2 Protein Inhibitors
Medical Subject Heading (MeSH) Categories for 209410
Suppliers and Packaging for NDA: 209410
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410 NDA Vertical Pharmaceuticals, LLC 68025-074 68025-074-62 1 KIT in 1 CARTON (68025-074-62) * 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-075-30) * 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-076-30)
OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410 NDA Vertical Pharmaceuticals, LLC 68025-075 68025-075-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-075-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 129MG BASE
Approval Date:Feb 16, 2018TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Feb 15, 2038Product Flag?Substance Flag?Delist Request?
Patented Use:A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT
Patent:  Start TrialPatent Expiration:Feb 15, 2038Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
Patent:  Start TrialPatent Expiration:Feb 15, 2038Product Flag?Substance Flag?Delist Request?
Patented Use:A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT

Expired US Patents for NDA 209410

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-001 Feb 16, 2018   Start Trial   Start Trial
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-003 Feb 16, 2018   Start Trial   Start Trial
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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