Details for New Drug Application (NDA): 209410
✉ Email this page to a colleague
NDA 209410 describes OSMOLEX ER, which is a drug marketed by Adamas Operations and is included in one NDA. It is available from one supplier. There are nineteen 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-two suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
The generic ingredient in OSMOLEX ER is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.
Summary for 209410
| Tradename: | OSMOLEX ER |
| Applicant: | Adamas Operations |
| Ingredient: | amantadine hydrochloride |
| Patents: | 19 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209410
| Mechanism of Action | M2 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 | Adamas Pharma, LLC | 70482-075 | 70482-075-07 | 2 BLISTER PACK in 1 CARTON (70482-075-07) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410 | NDA | Adamas Pharma, LLC | 70482-075 | 70482-075-14 | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (70482-075-14) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 129MG BASE | ||||
| Approval Date: | Feb 16, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 15, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 15, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 15, 2038 | Product 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 |
|---|---|---|---|---|---|---|---|
| Adamas Operations | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-003 | Feb 16, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| Adamas Operations | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-001 | Feb 16, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| Adamas Operations | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-002 | Feb 16, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
