Amantadine - Generic Drug Details
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Generic filers with tentative approvals for AMANTADINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | EQ 68.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 137MG | CAPSULE, EXTENDED RELEASE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
US Patents and Regulatory Information for amantadine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Supernus Pharms | GOCOVRI | amantadine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208944-001 | Aug 24, 2017 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Supernus Pharms | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-002 | Feb 16, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Rising | AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | CAPSULE;ORAL | 210129-001 | Mar 2, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Supernus Pharms | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-002 | Feb 16, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Supernus Pharms | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-003 | Feb 16, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Endo Operations | AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | SYRUP;ORAL | 077992-001 | Dec 12, 2006 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Supernus Pharms | GOCOVRI | amantadine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208944-002 | Aug 24, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |