Levomilnacipran - Generic Drug Details
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Generic filers with tentative approvals for LEVOMILNACIPRAN
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 120MG | CAPSULE, EXTENDED RELEASE;ORAL |
| ⤷ Start Trial | ⤷ Start Trial | 80MG | CAPSULE, EXTENDED RELEASE;ORAL |
| ⤷ Start Trial | ⤷ Start Trial | 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 | 204168-003 | Jul 25, 2013 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Aurobindo Pharma Ltd | LEVOMILNACIPRAN HYDROCHLORIDE | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 210826-002 | Jan 6, 2023 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Abbvie | FETZIMA | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168-004 | Jul 25, 2013 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Hikma | LEVOMILNACIPRAN HYDROCHLORIDE | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 210732-003 | Nov 5, 2020 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Abbvie | FETZIMA | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168-003 | Jul 25, 2013 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Abbvie | FETZIMA | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168-003 | Jul 25, 2013 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Prinston Inc | LEVOMILNACIPRAN HYDROCHLORIDE | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 210771-003 | Mar 20, 2023 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
