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USFDA APPLICATION NUMBER - 19641 / DOSAGE - SUPPOSITORY;VAGINAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| TERCONAZOLE(UNII: 0KJ2VE664U) (TERCONAZOLE - UNII:0KJ2VE664U) | TERCONAZOLE | 80mg | 8mg in 1 | 4mg in 1 |
Inactive Ingredients
| Ingredient Name | Janssen Pharmaceuticals, Inc. | Ortho-McNeil-Janssen Pharmaceutical |
|---|---|---|
| BUTYLATED HYDROXYANISOLE(REK4960K2U) | ||
| CETYL ALCOHOL(936JST6JCN) | ||
| COCONUT OIL(Q9L0O73W7L) | ||
| ISOPROPYL MYRISTATE(0RE8K4LNJS) | ||
| PALM KERNEL OIL(B0S90M0233) | ||
| POLYSORBATE 60(CAL22UVI4M) | ||
| POLYSORBATE 80(6OZP39ZG8H) | ||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||
| STEARYL ALCOHOL(2KR89I4H1Y) | ||
| WATER(059QF0KO0R) |
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