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USFDA APPLICATION NUMBER - 21029 / DOSAGE - CAPSULE;ORAL - 180MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| Temozolomide(UNII: YF1K15M17Y) (Temozolomide - UNII:YF1K15M17Y) | Temozolomide | 250mg | 180mg | 140mg | 100mg | 20mg | 5mg |
Inactive Ingredients
| Ingredient Name | ANI Pharmaceuticals, Inc. | Lannett Company, Inc. | Sandoz Inc. | Avera McKennan Hospital | Chemi Pharma LLC | Mylan Pharmaceuticals Inc. | Teva Pharmaceuticals USA, Inc. | Ascend Laboratories, LLC | IDT Australia Limited | Lotus Pharmaceutical Co., Ltd.Nantou Plant | Mayne Pharma Inc. |
|---|---|---|---|---|---|---|---|---|---|---|---|
| ALCOHOL(3K9958V90M) | |||||||||||
| ALUMINUM OXIDE(LMI26O6933) | |||||||||||
| AMMONIA(5138Q19F1X) | |||||||||||
| Anhydrous Lactose(3SY5LH9PMK) | |||||||||||
| BROWN IRON OXIDE(1N032N7MFO) | |||||||||||
| BUTYL ALCOHOL(8PJ61P6TS3) | |||||||||||
| D&C RED NO. 28(767IP0Y5NH) | |||||||||||
| D&C RED NO. 7(ECW0LZ41X8) | |||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | |||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | |||||||||||
| FD&C GREEN NO. 3(3P3ONR6O1S) | |||||||||||
| FD&C RED NO. 40(WZB9127XOA) | |||||||||||
| FD&C Yellow No. 6(H77VEI93A8) | |||||||||||
| Ferric Oxide Red(1K09F3G675) | |||||||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | |||||||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | |||||||||||
| Gelatin(2G86QN327L) | |||||||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | |||||||||||
| INDIGOTINDISULFONATE SODIUM(D3741U8K7L) | |||||||||||
| ISOPROPYL ALCOHOL(ND2M416302) | |||||||||||
| Methylparaben Sodium(CR6K9C2NHK) | |||||||||||
| Methylparaben(A2I8C7HI9T) | |||||||||||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | |||||||||||
| POVIDONE K29/32(390RMW2PEQ) | |||||||||||
| POVIDONE K30(U725QWY32X) | |||||||||||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | |||||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | |||||||||||
| Propylparaben Sodium(625NNB0G9N) | |||||||||||
| Propylparaben(Z8IX2SC1OH) | |||||||||||
| SHELLAC(46N107B71O) | |||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||
| SODIUM HYDROXIDE(55X04QC32I) | |||||||||||
| Sodium Lauryl Sulfate(368GB5141J) | |||||||||||
| SODIUM STARCH GLYCOLATE TYPE A CORN(AG9B65PV6B) | |||||||||||
| sodium starch glycolate type A potato(5856J3G2A2) | |||||||||||
| Stearic Acid(4ELV7Z65AP) | |||||||||||
| TARTARIC ACID(W4888I119H) | |||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) | |||||||||||
| Water(059QF0KO0R) |
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