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USFDA APPLICATION NUMBER - 21951 / DOSAGE - CAPSULE;ORAL - 30MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| ISOTRETINOIN(UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF) | ISOTRETINOIN | 10mg | 20mg | 30mg | 40mg | 25mg | 35mg |
Inactive Ingredients
| Ingredient Name | Teva Pharmaceuticals USA, Inc. | Mylan Pharmaceuticals Inc. | Ranbaxy Laboratories Inc. | Sun Pharmaceutical Industries, Inc. |
|---|---|---|---|---|
| ALPHA-TOCOPHEROL(H4N855PNZ1) | ||||
| AMMONIA(5138Q19F1X) | ||||
| BUTYLATED HYDROXYANISOLE(REK4960K2U) | ||||
| CORN OIL(8470G57WFM) | ||||
| D&C RED NO. 7(ECW0LZ41X8) | ||||
| D&C YELLOW NO. 10 ALUMINUM LAKE(CQ3XH3DET6) | ||||
| DIMETHICONE 350(2Y53S6ATLU) | ||||
| EDETATE DISODIUM(7FLD91C86K) | ||||
| EDETATE SODIUM(MP1J8420LU) | ||||
| FD&C BLUE NO. 1 ALUMINUM LAKE(J9EQA3S2JM) | ||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||||
| FD&C BLUE NO. 2--ALUMINUM LAKE(4AQJ3LG584) | ||||
| FD&C RED NO. 40(WZB9127XOA) | ||||
| FD&C YELLOW NO. 5(I753WB2F1M) | ||||
| FD&C YELLOW NO. 6(H77VEI93A8) | ||||
| FERRIC OXIDE RED(1K09F3G675) | ||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||
| FERROSOFERRIC OXIDE(XM0M87F357) | ||||
| GELATIN(2G86QN327L) | ||||
| GELATIN, UNSPECIFIED(2G86QN327L) | ||||
| GLYCERIN(PDC6A3C0OX) | ||||
| HYDROGENATED SOYBEAN OIL(A2M91M918C) | ||||
| LECITHIN, SOYBEAN(1DI56QDM62) | ||||
| MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U) | ||||
| PEG-32 HYDROGENATED PALM GLYCERIDES(G6EP177239) | ||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||
| POLYSORBATE 80(6OZP39ZG8H) | ||||
| POLYVINYL ACETATE PHTHALATE(58QVG85GW3) | ||||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | ||||
| POVIDONES(FZ989GH94E) | ||||
| PROPYL GALLATE(8D4SNN7V92) | ||||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||||
| SHELLAC(46N107B71O) | ||||
| SILICA, TRIMETHYLSILYL CAPPED(VU10KU4B9S) | ||||
| SODIUM HYDROXIDE(55X04QC32I) | ||||
| SORBITAN MONOOLEATE(06XEA2VD56) | ||||
| SOYBEAN OIL(241ATL177A) | ||||
| TITANIUM DIOXIDE(15FIX9V2JP) | ||||
| WHITE WAX(7G1J5DA97F) | ||||
| YELLOW WAX(2ZA36H0S2V) |
