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

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APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX38WYETH LAASn,I"'l,OHYDROXYZINE HCL, HYDROXYZINE HYDROCHLORIDELARGON. PROPIOMAZINE HYDROCHLORIDELIDOCAINE HCL, LIDOCAINE HYDROCHLORIDELO/OVRAL, ETHINYL ESTRADIOLLO/OVRAL-28, ETHINYL ESTRADIOLLO/OVRAL-28 AND FERROUS FUMERATE, ETHINYL ESTRADIOLMEPERGAN, MEPERIDINE HYDROCHLORIDEMEPERIDItre AND ATROPINE SULFATE, ATROPINE SULFATEMEPERIDINE HCL, MEPERIDINE HYDROCHLORIDEOMNIPEN (AMPICILLIN), AtIPICILLIN/AMPICILLIN TRIHYDRATEmINI PEN N, MIPICILLIN SODIUMOVRAL, ETHINYL ESTRADIOLOVRAL-28,. ETHINYL ESTRADIOLOVRAL-28 AND FERROUS FUMARATE, ETHINYL ESTRADIOLOVRETTE, NORGESTRELOXYTOCIN, OXYTOCINPATHOCIL, DICLOXICILLIN SODIUM MONOHYDRATEPEN-VEE K, PENICILLIN V POTASSIUMPENICILLIN G POTASSIUM, PENICILLIN G POTASSIUMPHENERGAl4, PRC!1ETHAZINE HYDROCHLORIDEPHENERGAN FORTIS, pqOMETHAZINE HYDROCHLORIDEPROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATEPROKETAZINE, CARPHENAZINE MALEATEREPOSITORY CORTICOTROPIN, CORTICOTROPINSERAX, OXAZEPAMSODIUM PENTOBARSITAL, PENTOBARBITAL SODIUMSODIUtl SECOBARBITAL, SECOBARBITAL SODIUMSPARINE, PR01'IAZINE HYDROCHLORIDESULFOSE, TRISULFAPYRIMIDINESTETRACYCLINE HCL, TETRACYCLINE HYDROCHLORIDETHIAMINE HCL, TIIIMIINE HYDROCHLORIDETH Iot1ER IN SOD IU:1, MERCAPTot1ER IN SOD IUMumPEN, NI',FCILLIN SODIUt1 r'lO}:OHYDRATE "'WYAMINE SULFATE, MEPHENTERMINE SULFATEWYAMYCIN E, ERYTHROMYCIN ETHYLSUCCINATEWYAMYCIN S, ERYTHRotlYCIN STEARATEWYCILLIN, PENICILLIN G PROCAINEWYDASE, HYALURO~IIDASEWYGESIC, ACETAtHNOPHENWYMOX, AMOXICILLIN TRIHYDRATE** Z **ZEt!:J:Tli LARSACETMIINOPHEN W CODEINE PHOSPHATE #3, ACETAMINOPHENACETANINOPHEN W/ CODEIt4E PHOSPHATE #4, ACETAMINOPHWAMPICI L LIN, AtlPICI L LIN/Af1PICI LLIN TR IHYDRATEAPC W/ BUTALBITAL, ASPIRINBETHANECHOL CHLORIDE, BETHANECHOL CHLORIDEBROMPHENIRAHINE MALEATE, BR011PHEIHRArnNE MALEATECEPHALEXIN MotIOHYDRATE, CEPHALEXIN MONOHYDRATE** Z **ZF.'HITH Lr.SSCHLORAMPHENICOL, CHLORAMPHENICOLCHLORDIAZEPOXIDE HCL, CHLORDIAZEPOXIDE HYDROCHLORIDECHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATECHLORPROMAZINE HCL, CHLORPROtlAZINE HYDROCHLORIDECONJUGATED ESTROGENS, ESTROGENS, CONJUGATEDCORTISONE ACETATE, CORTISOHE ACETATECYPROHEPTADINE HCL, CYPROHEPTADINE HYDROCHLORIDEo EXAtlETHASONE , DEXAMETHASONEDIPHENHYDRAMINE HCL, DIPHENHYDRAMINE HYDROCHLORIDEDIPHENOXYLATE HCL 14/ ATROPINE SULFATE, ATROPINE SULFATEERYTHROMYCIN STEARATE, ERYTHROMYCIN STEARATEFOLIC ACID, FOLIC ACIDGLUTETHItlIDE, GLUTETHIMIDEHYDRALAZINE HCL, HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HCL, HYDROCHLOROTHIAZIDE AND RESERPINE,HYDRALAZINE HYDROCHLORIDEHYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE 14/ RESERPINE, HYDROCHLOROTHIAZIDEISONIAZID, ISONIAZIDMECLIZINE HCL, MECLIZINE HYDROCHLORIDEMEPROBAMATE, MEPROBAMATEMETHOCARBAr10L, METHOCARBAMOLNIACIN, NIACINNITROFURANTOIH, NITROFURANTOINPENICILLIN G POTASSIUM, PENICILLIN G POTASSIUMPENICILLIN V POTASSIUM, PENICILLIN V POTASSIUMPHENDIt1ETRAZIHE TARTRATE, PHENDIMETRAZINE TARTRATEPHENTERMINE HCL, PHENTERMINE HYDROCHLORIDEPHENYTOIN SODIUM, PHENYTOIN SODIUMPREDNISOLONE, PREDNISOLONEPREDNISotlE, PREDNISot;EPROBENECID AtlO COLCHICINE, COLCHICINEPROCAINAMIDE HCL, PROCAINAMIDE HYDROCHLORIDEPROMETHAZINE HCL, PROMETHAZINE HYDROCHLORIDEPROPOXYPHENE COMPOUND 65, ASPIRINPROPOXYPHENE HCL. PROPOXYPHENE HYDROCHLORIDEPROPYLTHIOURACIL, PROPYLTHIOURACILQUINIDINE SULFATE, QUINIDINE SULFATERAU~:OLFIA SERPENTINA, RAUWOL!FIA SERPENTINARESERPINE, RESERPINESECOBARBITAL SODIUtl, SECOBARBITAL SODIUMSODIUM BUTABARBITAL, BUTABARBITAL SODIUtlSODIUM PEtlTOBARBITAL, PENTOBARBITAL SODIUMSPIRONOLACTONE, SPIRONOLACTONESPIRONOLACTONE 14/ HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDESULFISOXA20LE, SULFISOXAZOLETETRACYCLINE HCL, TETRACYCLINE HYDROCHLORIDETETRAMED, TETRACYCLINETOLBUTAMIDE, TOLBUTAMIDE
APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX39** z **ZEt-lJ:TH LABSTRIAMCINOLONE, TRIAMCINOLONETRIPLE SULFA #2, TRISULFAPYRIMIDINESVITAMIN A, VITAMIN A PALMITATE** 3 **3NSCRUBTEAH SURGICAL SPONGEBRUSH, HEXACHLOROPHENE
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RXD AND DRUG ACMINISTRATIONAPProVED
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approved application, a list of app
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products that have been approved" i
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To assist the user in relating the
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an evaluatien of therapeutic equiva
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ioavailability data is required for
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B - Drug products that FDA does not
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and the rate of absorption.pharmace
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4. Erythromycin stearate Tablets -
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II. LISTINGSA. FORMAT GUIDEThis p..
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CURRENT STATUS - POSSIBLY EFFECTIVE
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DRUG ProDUCT EKAMPLESSingle Ingredi
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APPROVED PRESCRIPTION DRUG PRODUCTS
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j./APPROVED PRESCRIPTION DRUG PRODU
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-,----APPROVED PRESCRIPTION DRUG PR
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APPROVED PRESCRI~TIOHDRUG PRODUCTSD
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DIMENHYDlHNATEAPPROVED PRESCRIPTION
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------"".,APPROVED PRESCRIPTION DRU
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APPROVED ¥RESCRIPTION DRUG PRODUCT
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Page 183 and 184: APPROVED PRESCRIPTION DRUG PRODUCTS
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