Levomilnacipran - Generic Drug Details
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Generic filers with tentative approvals for LEVOMILNACIPRAN
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 120MG | CAPSULE, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 80MG | CAPSULE, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 40MG | 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 levomilnacipran
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie | FETZIMA | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168-002 | Jul 25, 2013 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Aurobindo Pharma Ltd | LEVOMILNACIPRAN HYDROCHLORIDE | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 210826-003 | Jan 6, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Abbvie | FETZIMA | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168-001 | Jul 25, 2013 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hikma | LEVOMILNACIPRAN HYDROCHLORIDE | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 210732-004 | Nov 5, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |