
USFDA APPLICATION NUMBER - 22033 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| FLUVOXAMINE MALEATE(UNII: 5LGN83G74V) (FLUVOXAMINE - UNII:O4L1XPO44W) | FLUVOXAMINE MALEATE | 150mg | 100mg |
Inactive Ingredients
| Ingredient Name | Jazz Pharmaceuticals, Inc. |
|---|---|
| DIBUTYL SEBACATE(4W5IH7FLNY) | |
| FD&C BLUE NO. 2(L06K8R7DQK) | |
| FERRIC OXIDE RED(1K09F3G675) | |
| GELATIN(2G86QN327L) | |
| TALC(7SEV7J4R1U) | |
| TITANIUM DIOXIDE(15FIX9V2JP) |