
USFDA APPLICATION NUMBER - 208255 / DOSAGE - TABLET;ORAL - 400MG;300MG;300MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| EFAVIRENZ(UNII: JE6H2O27P8) (EFAVIRENZ - UNII:JE6H2O27P8) | EFAVIRENZ | 400mg |
| LAMIVUDINE(UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95) | LAMIVUDINE | 300mg |
| TENOFOVIR DISOPROXIL FUMARATE(UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5) | TENOFOVIR DISOPROXIL FUMARATE | 300mg |
Inactive Ingredients
| Ingredient Name | Macleods Pharmaceuticals Limited | Mylan Laboratories Limited |
|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | ||
| FERRIC OXIDE RED(1K09F3G675) | ||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||
| HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH) | ||
| HYPROMELLOSES(3NXW29V3WO) | ||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||
| MAGNESIUM STEARATE(70097M6I30) | ||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||
| POLOXAMER 188(LQA7B6G8JG) | ||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||
| POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | ||
| SODIUM LAURYL SULFATE(368GB5141J) | ||
| STARCH, CORN(O8232NY3SJ) | ||
| TALC(7SEV7J4R1U) | ||
| TITANIUM DIOXIDE(15FIX9V2JP) | ||
| TRIACETIN(XHX3C3X673) |