Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212182
Company: BIONPHARMA INC
Company: BIONPHARMA INC
| 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. |
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 | 091476 | ANCHEN PHARMS |
| FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 150MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212182 | BIONPHARMA INC |
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 | 091476 | ANCHEN PHARMS |
| FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212182 | BIONPHARMA INC |
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