first edition (1980) of the Orange Book - FDA Law Blog

More documents

Recommendations

Info

APPROVED PRESCRIPTION DRUG PRODUCTSTRADE NAME; INDEX3ESTERIFIED ESTROGENS, ESTROGENS, ESTERIFIEDESTINYL, ETHINYL ESTRADIOLESTRACE, ESTRADIOLESTRADIOL VALERATE, ESTRADIOL VALERATEESTRADURIN, POLYESTRADIOL PHOSPHATEESTRAGUARD, DIENESTROLESTRATAB, ESTROGENS, ESTERIFIEDESTROGENIC SUBSTANCE, ESTRONEESTRONE, ESTRONEESTROVIS, QUINESTROLETHAMID E, ETHOXZOLAMID EETHCHLORVYNOL, ETHCHLORVYNOLETHIODOL, ETHIODIZED OILETHRANE, ENFLURANEETHRIL 250, ERYTHROMYCIN STEARATEETHRIL 500, ERYTHROtIYCIN STEARATEETRAFON A, AMITRIPTYLINE HYDROCHLORIDEETRAFON 2-10, AMITRIPTYLINE HYDROCHLORIDEETRAFON 2-25, AMITRIPTYLINE HYDROCHLORIDEETRAFON-FORTE, AtlITRIPTYLINE HYDROCHLORIDEEURAX, CROTAMITONEUTHROID-O.5, LEVOTHYROXINE SODIUMEUTHROID-l, LEVOTHYROXINE SODIUMEUTHROID-2, LEVOTHYROXINE SODIUMEUTHROID-3, LEVOTHYROXINE SODIUMEUTONYL, PARGYLINE HYDROCHLORIDEEUTRON, METHYCLOTHIAZIDEEVEX, ESTROSENS, ESTERIFIEDEXt~A, BENZTHIAZIDEEXNA-R, BENZTHIAZIDEEXSEL, SELENIUM SULFIDE** F **FASTIN, PHENTERMINE HYDROCHLORIDEFEMINONE, ETHINYL ESTRADIOLFEMOGEN, ESTROGENS, ESTERIFIEDFENYLHIST, DIPHEtlHYDRAMINE HYDROCHLORIDEFENYLHIST-25, DIPHENHYDRAMINE HYDROCHLORIDEFERNOEX, DEXTROAtlPIlETAMINE SULFATEFERNISOLONE, PREDNISOLONE ACETATEFERNISOLONE-P, P~EDNISOLONEFERNISONE, PREDNISONEFERROUS CITRATE FE 59, FERROUS CITRATE, FE-59FIORINAL, ASPIRINFLAGYL, METRONIDAZOLEFLAXEDIL, GALLAMIt~E TRIETHIODIDEFLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDEFLORINEF, FLUDROCORTISONE ACETATEFLORONE, DIFLORASONEDIACETATEFLOROPRYL, ISOFLUROPHATEFLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDEFLUONIO, FLUOCINOLONE ACETONIDEFLUOROPLEX, FLUOROURACILFLUOROURACIL, FLUOROURACILFLUOTHANE, HALOTHANEFLUTEX, TRIAMCINOLONE ACETONIDEFMLll;'FLUOROMETHOLONEFO~lC ACID, FOLIC ACIDFOLLUTEIN, GOl~ADOTROPIN, CHORIONICFOLVITE, FOLATE SODIUMFOLVITE, FOLIC ACIDFOLVRON, FERROUS SULFATEFOLVRON G, ASCORBIC ACIDFORANE. ISOFLURANEFORBAXIN, METHOCARBAMOLFOVANE, BENZTHIAZIDEFREAMItlE II 8.57., AMItlO ACIDSFREAMINE III 37. W/ ELECTROLYTES, AMINO ACIDSFREAMINE III 8.57.. AMINO ACIDSFREAtlINE 8.57., AtlINO ACIDSFUDR, FLOXURIDINEFULVICIN-P/G, GRISEOFULVIN, ULTRAtlICROCRYSTALLINEFULVICIN-U/F, GRISEOFULVIN, MICROCRYSTALLINEFUNDUSCEIN-25, FLUORESCEIN SODIUMFUNGIZONE, AMPHOTERICIN BFURACIN, NITROFURAZONEFURADANTIN, NITROFURANTOINFURALAN, NITROFURANTOINFUROSEMIDE. FUROSEMIDEFUROXONE, FURAZOLIDONE** G **GALLIUM CITRATE GA 67, GALLIUM CITRATE, GA-67GAM ENE , LINDAtlEGAHOPHEN, HEXACHLOROPHENEGANTANOL, SULFAMETHOXAZOLEGANTANOL-OS, SULFAMETHOXAZOLEGANTRIsnt, SULFISOXAZOLEGA.NTRISIN, SULFISOXAZOLE ACETYLGANTRISIN, SULFISOXAZOLE DIOLAMINEGAtHRISIN PEDIATRIC, SULFISOXAZOLE ACETYLGARAtIYCIN, GENTAMICIN SULFATEi GASTROGRAFIN, DIATRIZOATE MEGLUMINE} GEMmIll, tlETHARBITAL~·G'WAPAX, GENTIAN VIOLETGEOCILLIN, CARBENICILLIN INDANYL SODIUMGEOPEN, CARBENICILLIN DISODIUMGERMA-MEOICA, HEXACHLOROPHENEGERMA-HEDICA ~lG, HEXACHLOROPHENEGLOFIL-125, IOTHALAMATE SODIUM, 1-125
APPROVED PRESCRIPTION DRUG PRODUCTSTRADE NAME INDEX9GLUCAGON, GLUCAGON HYDROCHLORIDEGLUCOSCAN, TECHNETIUM, TC-99M, GLUCEPTATE KITGLUTETHIMIDE, GLUTETHU1IDEGLYCINE 1.5X IN PLASTIC CONTAINER, AMINOACETIC ACIDGLYCOPYRROLATE, GLYCOPYRROLATEGLYESTRIN, ESTROGENS, ESTERIFIEDGLYNAZAN, THEOPHYLLINE SODIUM GLYCINATEGRIFULVIN V, GRISEOFULVIN, MICROCRYSTALLINEGRIS-PEG, GRISEOFULVIN, UL TRAI1ICROCRYSTALLINEGRISACTIN, GRISEOFULVIN, MICROCRYSTALLINEGRISACTIN ULTRA, GRISEOFULVIN, ULTRAMICROCRYSTALLINEGRISOWEN, GRISEOFULVIN, MICROCRYSTALLINEGUANIDINE HCL, GUANIDINE HYDROCHLORIDEGVS, GENTIAN VIOLETGYNE-LOTRIMIN, CLOTRIMAZOLEGYNOREST, DYDROGESTERONE** H **H.P. ACTHAR GEL, CORTICOTROPINH.R.-50, HYDROCHLOROTHIAZIDEH-CORT, HYDROCORTISONEHALCIDERM, HALCINONIDEHALDOL, HALOPERIDOLHALDRONE, PARAMETHASONE ACETATEHALODRIN, ETHINYL ESTRADIOLHALOG, HALCINONIDEHALOTESTIN, FLUOXYMESTERONEHALOTEX, HALOPROGINHALOTHANE, HALOTHANEHARMONYL, DESERPIDINEHC (HYDROCORTISONE), HYDROCORTISONEHC #1, HYDROCORTISONEHC #4, HYDROCORTISONEHEDULIN, PHENINDIONEHEP-LOCK, HEPARIN SODIUMHEPARIN, HEPARIN SODIUMHEPARIN LOCK FLUSH, HEPARIN SODIUMHEP.ARIN SODIUM, HEPARIN SODIUMHEPARIN SODIUM IN NORMAL SALINE, HEPARIN SODIUMHEPRINAR, HEPARIN SODIUMHERPLEX, IDOXURIDINEHETR~.ZAN, DIETHYLCARBAMAZINE CITRATEHEXA-BETALIN, PYRIDOXINE HYDROCHLORIDEHEXA-GERM, HEXACHLOROPHENEHEXADROL, DEXAMETHASONEHEXADROL, DEXAMETHASONE SODIUM PHOSPHATEHEXADROL PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATEHI-COR, HYDROCORTISONEHIPPURAN I 131, IODOHIPPURATE SODIUM, 1-131HIPPUTOPE, IODOHIPPURATE SODIUM, 1-131HIPREX, METHENAMINE HIPPURATEHISERPIA, RESERPINEHISTALOG, BETAZOLE HYDROCHLORIDEHISTAMINE PHOSPHATE, HISTAMINE PHOSPHATEHISTREY, CHLORPHENIRAMINE MALEATEHIWOLFIA, RAUWOLFIA SERPENTINAHMS, MEDRYSONEHOMAPIN-10, HOMATROPINE METHYLBROMIDEHOMAPIN-5, HOMATROPINE METHYLBROMIDEHUMATIN, PAROMOMYCIN SULFATEHUMORSOL, DEMECARIUM BROMIDEHYCORTOLE, HYDROCORTISONEHYDELTRA TBA, PREDNISOLONE TEBUTATEHYDELTRASOL, PREDNISOLONE SODIUM PHOSPHATEHYDERGINE, DIHYDROERGOCORNINE MESYLATEHYDRALAZINE AND HYDROCHLORTHIAZIDE, HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HCL, HYDRALAZINE ·HYDROCHLORIDEHYDRALAZINE HCL, HYDROCHLOROTHIAZIDE AND RESERPINE, HYDRALAZINEHYDROCHLORIDEHYDRALAZINE, HYDROCHLOROTHIAZIDE WI RESERPINE, HYDRALAZINEHYDROCHLORIDEHYORAMINE, DIPHENHYDRAMINE HYDROCHLORIDEHYDREA, HYDROXYUREAHYDRO-D, HYDROCHLOROTHIAZIDEHYDRO-RESERP, HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE WI HYDRALAZINE, HYDRALAZINE HYDROCHLORIDEHYDROCHLOROTHIAZIDE WI RESERPINE, HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE WI RESER~INE AND HYDRALAZINE, HYDRALAZINEHYDROCHLORIDEHYDROCHLOROTHIAZIDE, HYDRALAZINE HCL AND RESERPINE, HYDRALAZINEHYDROCHLORIDEHYDROCOBALAI1IN, HYDROXOCOBALAMINHYDROCORTISONE, HYDROCORTISONEHYDROCORTISONE, HYDROCORTISONE ACETATEHYDROCORTISONE ACETATE, HYDROCORTISONE ACETATEHYDROCORTONE, HYDROCORTISONEHYDROCORTONE, HYDROCORTISONE ACETATEHYDROCORTONE, HYDROCORTISO~E SODIUM PHOSPHATEHYDRODIURIL, HYDROCHLOROTHIAZIDEHYDROGENATED ERGOT ALKALOIDS, DIHYDROERGOCORNINE MESYLATEHYDROMOX, QUINETHAZONEHYDROMOX R, QUINETHAZONEHYDROPRES-25, HYDROCHLOROTHIAZIDEHYDROPRES-50, HYDROCHLOROTHIAZIDEHYDROXOCOBALAMIN, HYDROXOCOBALAMINHYDROXYPROGESTERONE CAPROATE, HYDROXYPROGESTERONE CAPROATEHYDROXYSTILBAMIDINE ISETHIONATE, HYDROXYSTILBAMIDINE ISETHHlNATEHYDROXYZINE HCL, HYDROXYZINE HYDROCHLORIDEHYGROTON, CHLORTHALIDONEHYPAQUE, DIATRIZOATE MEGLUMINE
Page 5:
RXD AND DRUG ACMINISTRATIONAPProVED
Page 9:
approved application, a list of app
Page 12 and 13:
products that have been approved" i
Page 14 and 15:
To assist the user in relating the
Page 16 and 17:
an evaluatien of therapeutic equiva
Page 18 and 19:
ioavailability data is required for
Page 20 and 21:
B - Drug products that FDA does not
Page 22 and 23:
and the rate of absorption.pharmace
Page 24 and 25:
4. Erythromycin stearate Tablets -
Page 27 and 28:
II. LISTINGSA. FORMAT GUIDEThis p..
Page 29 and 30:
CURRENT STATUS - POSSIBLY EFFECTIVE
Page 31 and 32:
DRUG ProDUCT EKAMPLESSingle Ingredi
Page 33 and 34:
APPROVED PRESCRIPTION DRUG PRODUCTS
Page 35 and 36:
Page 37 and 38:
Page 39 and 40:
Page 41 and 42:
Page 43 and 44:
Page 45 and 46:
Page 47 and 48:
Page 49 and 50:
Page 51 and 52:
Page 53 and 54:
Page 55 and 56:
j./APPROVED PRESCRIPTION DRUG PRODU
Page 57 and 58:
Page 59 and 60:
Page 61 and 62:
Page 63 and 64:
Page 65 and 66:
-,----APPROVED PRESCRIPTION DRUG PR
Page 67 and 68:
APPROVED PRESCRI~TIOHDRUG PRODUCTSD
Page 69 and 70:
Page 71 and 72:
Page 73 and 74:
Page 75 and 76:
Page 77 and 78:
DIMENHYDlHNATEAPPROVED PRESCRIPTION
Page 79 and 80:
Page 81 and 82:
------"".,APPROVED PRESCRIPTION DRU
Page 83 and 84:
Page 85 and 86:
Page 87 and 88:
Page 89 and 90:
Page 91 and 92:
APPROVED ¥RESCRIPTION DRUG PRODUCT
Page 93 and 94:
Page 95 and 96:
'''"APPROVED PRESCRIPTION DRUG PROD
Page 97 and 98:
----..//APPROVED PRESCRIPTION DRUG
Page 99 and 100:
Page 101 and 102:
Page 103 and 104:
Page 105 and 106:
Page 107 and 108:
Page 109 and 110:
Page 111 and 112:
Page 113 and 114:
Page 115 and 116:
Page 117 and 118:
Page 119 and 120:
Page 121 and 122:
Page 123 and 124:
Page 125 and 126:
"~''''''-- .APPROVED PRESCRIPTION D
Page 127 and 128:
Page 129 and 130:
Page 131 and 132: APPROVED PRESCRIPTION DRUG PRODUCTS
Page 181: APPROVED PRESCRIPTION DRUG PRODUCTS
Page 189 and 190: PERCORTEN PIVALATE, DESOXYCORTICOST
Page 195: oAPPROVED PRESCRIPTION DRUG PRODUCT
Page 224 and 225: APPROVED PRESCRIPTIOH DRUG PRODUCTS
Page 232 and 233:
Page 234 and 235:
Page 237 and 238:
Page 239 and 240:
Page 241 and 242:
Page 243:
Page 246 and 247:
PRESCRIPTION DRUG PRODUCTS DEEMED A
Page 248 and 249:
Page 250 and 251:
show all

first edition (1980) of the Orange Book - FDA Law Blog

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?