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1、FDA常用辅料及用量目录LIGHTMINERALOIL0GLYCERIN1EDETATEDISODIUM7SORBIC17SODIUMPHOSPHATE,DIBASIC19SODIUMPHOSPHATE,MONOBASIC30SILICONDIOXIDE40CELLULOSE,MICROCRYSTALLINE47COPOVIDONE48CROSPOVIDONE49SODIUMSTARCHGLYCOLATE58MAGNESIUMSTEARATE60HYPROMELLOSE65BUTYLATEDHYDROXYANISOLE74PROPYL
2、ENEGLYCOL76PROPYLGALLATE7862LIGHTMINERALOILINACTIVEINGREDIENTROUTE;DOSAGEFORMCASNUMBERUNIIMAXIMUMPOTENCYLIGHTMINERALOILOPHTHALMIC;OINTMENT8012951N6K5787QVPLIGHTMINERALOILOPHTHALMIC;SUSPENSION8012951N6K5787QVPLIGHTMINERALOILORAL;CAPSULE8012951N6K5787QVP0.80MGLIGHTMINERAL
3、OILORAL;CAPSULE,ENTERICCOATEDPELLETS8012951N6K5787QVP14.10MGLIGHTMINERALOILORAL;CAPSULE,SOFTGELATIN8012951N6K5787QVPLIGHTMINERALOILORAL;PASTILLE8012951N6K5787QVP3.60MGLIGHTMINERALOILORAL;TABLET8012951N6K5787QVP1474.00MGLIGHTMINERALOILORAL;TABLET,COATED8012951N6K5787QVP4
4、.80MGLIGHTMINERALOILORAL;TABLET,FILMCOATED8012951N6K5787QVP2.49MGLIGHTMINERALOILORAL;TABLET,SUSTAINEDACTION8012951N6K5787QVP0.20MGLIGHTMINERALOILRECTAL;SUSPENSION8012951N6K5787QVPLIGHTMINERALOILTOPICAL;CREAM,AUGMENTED8012951N6K5787QVP25.00%LIGHTMINERALOILTOPICAL;EMULSIO
5、N8012951N6K5787QVP5.00%LIGHTMINERALOILTOPICAL;EMULSION,AEROSOLFOAM8012951N6K5787QVP6.00%LIGHTMINERALOILTOPICAL;EMULSION,CREAM8012951N6K5787QVP20.00%LIGHTMINERALOILTOPICAL;LOTION8012951N6K5787QVP16.00%LIGHTMINERALOILTOPICAL;OINTMENT8012951N6K5787QVP23.00%LIGHTMINERALOILT
6、RANSDERMAL;FILM,CONTROLLEDRELEASE8012951N6K5787QVP162.00MG62LIGHTMINERALOILTRANSDERMAL;PATCH8012951N6K5787QVP74.00MGLIGHTMINERALOIL(85SSU)TOPICAL;EMULSION,CREAM8012951N6K5787QVPglycerinINACTIVEINGREDIENTROUTE;DOSAGEFORMCASNUMBERUNIIMAXIMUMPOTENCYGLYCERINAURICULAR(OTIC);
7、SOLUTION000056815PDC6A3C0OX60.00%GLYCERINAURICULAR(OTIC);SOLUTION,DROPS000056815PDC6A3C0OX63.63%GLYCERINAURICULAR(OTIC);SUSPENSION000056815PDC6A3C0OX0.05%GLYCERINBUCCAL;GUM,CHEWING000056815PDC6A3C0OX28.80MGGLYCERINBUCCAL;PATCH,CONTROLLEDRELEASE000056815PDC6A3C0OX66.00MG
8、GLYCERINDENTAL;PASTE000056815PDC6A3C0OXGLYCERINDENTAL;SOLUTION000056815PDC6A3C0OX15.00%GLYCERINDENTAL;TABLET00