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USFDA APPLICATION NUMBER - 21951 / DOSAGE - CAPSULE;ORAL - 40MG
| 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. | Ranbaxy Laboratories Inc. | Sun Pharmaceutical Industries, Inc. |
|---|---|---|---|
| ALPHA-TOCOPHEROL(H4N855PNZ1) | |||
| AMMONIA(5138Q19F1X) | |||
| BUTYLATED HYDROXYANISOLE(REK4960K2U) | |||
| D&C RED NO. 7(ECW0LZ41X8) | |||
| D&C YELLOW NO. 10 ALUMINUM LAKE(CQ3XH3DET6) | |||
| DIMETHICONE 350(2Y53S6ATLU) | |||
| EDETATE DISODIUM(7FLD91C86K) | |||
| 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) | |||
| HYDROGENATED SOYBEAN OIL(A2M91M918C) | |||
| PEG-32 HYDROGENATED PALM GLYCERIDES(G6EP177239) | |||
| POLYSORBATE 80(6OZP39ZG8H) | |||
| 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) |
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