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USFDA APPLICATION NUMBER - 21316 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| LOVASTATIN(UNII: 9LHU78OQFD) (LOVASTATIN - UNII:9LHU78OQFD) | LOVASTATIN | 60mg | 40mg | 20mg |
Inactive Ingredients
| Ingredient Name | Covis Pharma US, Inc | Shionogi Inc. |
|---|---|---|
| ACETYLTRIBUTYL CITRATE(0ZBX0N59RZ) | ||
| BUTYLATED HYDROXYANISOLE(REK4960K2U) | ||
| CANDELILLA WAX(WL0328HX19) | ||
| CELLULOSE ACETATE(3J2P07GVB6) | ||
| FD&C YELLOW NO. 6(H77VEI93A8) | ||
| FERRIC OXIDE RED(1K09F3G675) | ||
| FERROSOFERRIC OXIDE(XM0M87F357) | ||
| GLYCERYL MONOSTEARATE(230OU9XXE4) | ||
| HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(87Y6436BKR) | ||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||
| HYPROMELLOSES(3NXW29V3WO) | ||
| LACTOSE, UNSPECIFIED FORM(J2B2A4N98G) | ||
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577) | ||
| POLYETHYLENE GLYCOL 400(B697894SGQ) | ||
| POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | ||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | ||
| POLYSORBATE 80(6OZP39ZG8H) | ||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||
| SODIUM CHLORIDE(451W47IQ8X) | ||
| SODIUM LAURYL SULFATE(368GB5141J) | ||
| SUCROSE(C151H8M554) | ||
| TALC(7SEV7J4R1U) | ||
| TITANIUM DIOXIDE(15FIX9V2JP) | ||
| TRIACETIN(XHX3C3X673) |
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