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USFDA APPLICATION NUMBER - 20083 / DOSAGE - CAPSULE;ORAL - 100MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| ITRACONAZOLE(UNII: 304NUG5GF4) (ITRACONAZOLE - UNII:304NUG5GF4) | ITRACONAZOLE | 100mg |
Inactive Ingredients
| Ingredient Name | Bryant Ranch Prepack | REMEDYREPACK INC. | Eon Labs, Inc. | Jubilant Cadista Pharmaceuticals Inc. | Vensun Pharmaceuticals, Inc. | Mylan Pharmaceuticals Inc. |
|---|---|---|---|---|---|---|
| ALCOHOL(3K9958V90M) | ||||||
| AMMONIA(5138Q19F1X) | ||||||
| BUTYL ALCOHOL(8PJ61P6TS3) | ||||||
| D&C RED NO. 22(1678RKX8RT) | ||||||
| D&C Red No. 28(767IP0Y5NH) | ||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | ||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||||||
| FD&C RED NO. 3(PN2ZH5LOQY) | ||||||
| FD&C RED NO. 40(WZB9127XOA) | ||||||
| FERRIC OXIDE RED(1K09F3G675) | ||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | ||||||
| GELATIN(2G86QN327L) | ||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | ||||||
| HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) | ||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||||
| Hypromelloses(3NXW29V3WO) | ||||||
| ISOPROPYL ALCOHOL(ND2M416302) | ||||||
| METHYLENE CHLORIDE(588X2YUY0A) | ||||||
| POLOXAMER 188(LQA7B6G8JG) | ||||||
| POLYETHYLENE GLYCOL 20000(5WKN5KL2O8) | ||||||
| Polyethylene Glycol, Unspecified(3WJQ0SDW1A) | ||||||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | ||||||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | ||||||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | ||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||||||
| SHELLAC(46N107B71O) | ||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||
| SODIUM HYDROXIDE(55X04QC32I) | ||||||
| SODIUM LAURYL SULFATE(368GB5141J) | ||||||
| Starch, Corn(O8232NY3SJ) | ||||||
| Sucrose(C151H8M554) | ||||||
| TALC(7SEV7J4R1U) | ||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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