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USFDA APPLICATION NUMBER - 21951 / DOSAGE - CAPSULE;ORAL - 35MG
| 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 | Ranbaxy Laboratories Inc. | Sun Pharmaceutical Industries, Inc. |
|---|---|---|
| FD&C BLUE NO. 1(H3R47K3TBD) | ||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||
| 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) | ||
| PEG-32 HYDROGENATED PALM GLYCERIDES(G6EP177239) | ||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | ||
| POVIDONES(FZ989GH94E) | ||
| PROPYL GALLATE(8D4SNN7V92) | ||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||
| SHELLAC(46N107B71O) | ||
| SODIUM HYDROXIDE(55X04QC32I) | ||
| SORBITAN MONOOLEATE(06XEA2VD56) | ||
| SOYBEAN OIL(241ATL177A) | ||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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