Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212182
Company: BIONPHARMA
Company: BIONPHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 150MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/11/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/21/2023 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/18/2023 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
FLUVOXAMINE MALEATE
CAPSULE, EXTENDED RELEASE;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 150MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091482 | ACTAVIS ELIZABETH |
| FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 150MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212182 | BIONPHARMA |
| FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 150MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091476 | ENDO OPERATIONS |
CAPSULE, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091482 | ACTAVIS ELIZABETH |
| FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212182 | BIONPHARMA |
| FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091476 | ENDO OPERATIONS |