Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204168
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 80MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | EQ 120MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/25/2013 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204168s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204168Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204168Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204168Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/19/2024 | SUPPL-12 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020822Orig1s055; 021365Orig1s041; 021323Orig1s058; 022567Orig1s025; 204168Orig1s012ltr.pdf |
| 08/18/2023 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204168s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204168Orig1s011,022567Orig1s024ltr.pdf | |
| 03/24/2023 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204168s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204168Orig1s010ltr.pdf | |
| 09/20/2021 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204168s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020822Orig1s052, 021365Orig1s038, 021323Orig1s053, 022567Orig1s022, 204168Orig1s007ltr.pdf | |
| 10/07/2019 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204168s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204168Orig1s006ltr.pdf | |
| 12/19/2017 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204168s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204168Orig1s005ltr.pdf | |
| 01/04/2017 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204168s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204168Orig1s004ltr.pdf | |
| 06/05/2015 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/2014 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204168s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204168Orig1s002ltr.pdf | |
| 05/23/2014 | SUPPL-1 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204168Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204168Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204168s011lbl.pdf | |
| 03/24/2023 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204168s010lbl.pdf | |
| 09/20/2021 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204168s007lbl.pdf | |
| 09/20/2021 | SUPPL-7 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204168s007lbl.pdf | |
| 10/07/2019 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204168s006lbl.pdf | |
| 12/19/2017 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204168s005lbl.pdf | |
| 01/04/2017 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204168s004lbl.pdf | |
| 07/18/2014 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204168s002lbl.pdf | |
| 05/23/2014 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204168Orig1s001lbl.pdf | |
| 07/25/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204168s000lbl.pdf |
FETZIMA
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 |