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USFDA APPLICATION NUMBER - 16792 / DOSAGE - CAPSULE;ORAL - EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| TRIMIPRAMINE MALEATE(UNII: 269K6498LD) (TRIMIPRAMINE - UNII:6S082C9NDT) | TRIMIPRAMINE | 100mg | 50mg | 25mg |
Inactive Ingredients
| Ingredient Name | Teva Women's Health, Inc. |
|---|---|
| ALUMINUM OXIDE(LMI26O6933) | |
| AMMONIA(5138Q19F1X) | |
| BENZYL ALCOHOL(LKG8494WBH) | |
| BUTYLPARABEN(3QPI1U3FV8) | |
| D&C RED NO. 28(767IP0Y5NH) | |
| D&C YELLOW NO. 10(35SW5USQ3G) | |
| EDETATE CALCIUM DISODIUM(25IH6R4SGF) | |
| FD&C BLUE NO. 1(H3R47K3TBD) | |
| FD&C BLUE NO. 2(L06K8R7DQK) | |
| FD&C RED NO. 40(WZB9127XOA) | |
| FD&C YELLOW NO. 6(H77VEI93A8) | |
| FERROSOFERRIC OXIDE(XM0M87F357) | |
| GELATIN(2G86QN327L) | |
| INDIGOTINDISULFONATE SODIUM(D3741U8K7L) | |
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |
| MAGNESIUM STEARATE(70097M6I30) | |
| METHYLPARABEN(A2I8C7HI9T) | |
| POTASSIUM HYDROXIDE(WZH3C48M4T) | |
| PROPYLENE GLYCOL(6DC9Q167V3) | |
| PROPYLPARABEN(Z8IX2SC1OH) | |
| SHELLAC(46N107B71O) | |
| SODIUM LAURYL SULFATE(368GB5141J) | |
| SODIUM PROPIONATE(DK6Y9P42IN) | |
| TITANIUM DIOXIDE(15FIX9V2JP) |
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