Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210771
Company: PRINSTON INC
Company: PRINSTON INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVOMILNACIPRAN HYDROCHLORIDE | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
LEVOMILNACIPRAN HYDROCHLORIDE | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
LEVOMILNACIPRAN HYDROCHLORIDE | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 80MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
LEVOMILNACIPRAN HYDROCHLORIDE | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 120MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/20/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210771Orig1s000TA_ltr.pdf |
LEVOMILNACIPRAN HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL; EQ 20MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 204168 | ABBVIE |
LEVOMILNACIPRAN HYDROCHLORIDE | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210771 | PRINSTON INC |
CAPSULE, EXTENDED RELEASE;ORAL; EQ 40MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 204168 | ABBVIE |
LEVOMILNACIPRAN HYDROCHLORIDE | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210771 | PRINSTON INC |
CAPSULE, EXTENDED RELEASE;ORAL; EQ 80MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 80MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 204168 | ABBVIE |
LEVOMILNACIPRAN HYDROCHLORIDE | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 80MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210771 | PRINSTON INC |
CAPSULE, EXTENDED RELEASE;ORAL; EQ 120MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 120MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 204168 | ABBVIE |
LEVOMILNACIPRAN HYDROCHLORIDE | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 120MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210771 | PRINSTON INC |