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

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APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX12DIAGNOSTIC ISOTO~ESXENON XE 133. XENON. XE-133DIAGNOSTIC P~OOS/!HALButUN mCROSPHERES (HUMAN) INSTANT MICROSPHERES,TECHt{ETIUM, TC-99M. ALBUMIN AGGREGATED KITYTTERBIUM YB 169 DTPA, PENETATE CALCIUM TRISODIUM, YB-169DISTA r~OOS/lILLYCORDRAN. FLURAtIDRENOLIDECORDRAN SP, FLURANDRENOLIDEERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE!LOSONE, ERYTHRO~IYCIN ESTOLATEI LOnCIN, ERYTHRO~IYCINILOTYCIN GLUCEPTATE, ERYTHROMYCIN GLUCEPTATENALFON, FENOPROFEN CALCIUM DIHYDRATEPENICILLIN G POTASSIUM, PENICILLIN G POTASSIUMVALMID, ETHINAMATEDOM/! LABS//1:.'!:U!; LAI3SANTAGONATE, CHLORPHENIRAMINE MALEATECANDEX, NYSTATINCORT-DOME, HYDROCORTISONEDELTA-DOME, PREDNISONEDO~IEBORO, ACETIC ACID, GLACIALOTIC-DOME, DACAR8AZINEHC #l, HYDROCORTISmlEHC #4, HYDROCORTISONELITHANE, LITHIUM CARBONATEMYCELEX, CLOTRIMAZOLEMYCELEX-G, CLOTRIMAZOLENEO-CORT -D0l1E, ACETIC ACID, GLACIALNYSTAFORM, IODOCHLORHYDROXYQUINSOY-DONE, HEXACHLOROPHENESTILPHOSTROL, DIETHYLSTILBESTROL DIPHOSPHATETRIDESILON, ACETIC ACID, GLACIALTRIDESILON, DESONIDEVI-DOM-A, VITAMIN A PALMITATEDOOMER LABSSLO-PHYLLIN, THEOPHYLLINESLO-PHYlLIN-80, THEOPHYLLINEDO~SEYLABS/SAN~OZASBRON, THEOPHYLLINE SODIUM GLYCINATEDORSACAINE, BENOXINATE HYDROCHLORIDEGRIS-PEG, GRISEOFULVIN, ULTRAMICROCRYSTALLINERAUTENSIN, ALSEROXYLONTAVIST, CLEMASTINE FU~IARATETAVIST-l, CLEMASTINE FUMARATETREST, METHIXENE HYDROCHLORIDEDOW PHAl?HSDO~j-ISONIAZID. ISONIAZIDDYCLmIE, DYCLONINE HYDROCHLORIDELORELCO, PROBUCOLNEO-POLYCIN, BACITRACIN ZINCNEO-POLYCIN, GRAr1ICIDINNOVAFED, PSEUDOEPHEDRINE HYDROCHLORIDEPHENOXENE, CHLORPHENOXAMINE HYDROCHLORIDEQUIDE. PIPERACETAZINERIFADIN, RIFAMPINRIFAMATE, ISONIAZID** E **E rOUGERA/BYK-GUlDEHETHIODOL, ETHIODIZED OILLIDOCAINE, LIDOCAINESULFACETAMIDE SODIUM, SULFACETAMIDE SODIUMELI LILLYAEROLGtlE, ISOPROTERENOL HYDROCHLORIDEALPHALIN, VITAMIN A PALMITATEAMINOSALICYLIC ACID, AMINOSALICYLIC ACIDANHYDRON, CYCLOTHIAZIDEAVENTYL HCL, NORTRIPTYLINE HYDROCHLORIDEBACITRACIN, BACITRACINBETALIN S, THIAMINE HYDROCHLORIDEBETA LIN 12, CYANOCOBALAMINBREVITAL SODIUM, METHOHEXITAL SODIUMCALCIUM GLUCEPTATE, CALCIUM GLUCEPTATECAPASTAT SULFATE, CAPREOMYCIN SULFATECECLOR, CEFACLOR MONOHYDRATECINOBAC, CINOXACINCRYSTODIGIN, DIGITOXINCYTELLIN, SITOSTEROLDARVOCET-N 100, ACETAMINOPHENDARVOCET-N 50, ACETAMINOPHENDARVON, PROPOXYPHENE HYDROCHLORIDEDARVDtI COMPOUND, ASPIRINDARVON COMPOUND 65, ASPIRINDARVON W/ ASA, ASPIRINDARVON-N, PROPOXYPHENE NAPSYLATEDARYON-N W/ ASA. ASPIRINDELTALIN, ERGOCALCIFEROLDICUMAROL, BISHYDROXYCOUMARINDICURIN PROCAINE, PROCAINE M~RETHOXYLLINEDIETHYLSTILBESTROL, DIETHYLSTILBESTROLDOBUTREX, DOBUTAMINE HYDROCHLORIDEDOLOPHINE HCL, METHADONE HYDROCHLORIDEDROLBAN, DROMOSTANOLONE PROPIONATEDURACILLIN A.S., PENICILLIN G PROCAINEDYMELOR, ACETOHEXAMIDE
APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX13ELI: LI:LLYFOLIC ACID. FOLIC ACIDGLUCAGON, GLUCAGON HYDROCHLORIDEHALDRONE, PARAMETHASONE ACETATEHEPARIN SODIUM, HEPARIN SODIUMHEXA-BETALIN, PYRIDOXINE HYDROCHLORIDEHISTALOG, BETAZOLE HYDROCHLORIDEHISTAMINE PHOSPHATE, HISTAMINE PHOSPHATEILETIN, INSULIN, PORKILETIN II, INSULIN, PURIFIED PORKISONIAZID, ISONIAZIDKAFOCIN, CEPHALOGLYCINKAPPADIONE, MENADIOL SODIUM DIPHOSPHATEKEFLEX, CEPHALEXIN MONOHYDRATEKEFLIN, CEPHALOTHIN SODIUMKEFZOL, CEFAZOLIN SODIUMLORIDINE, CEPHALORIDINEMAl-mOL, CEFAMANDOLE NAFATEMENADIONE, MENADIONEMETHADONE HCL, METHADONE HYDROCHLORIDEMETHYLTESTOSTERONE, METHYLTESTOSTERONEMETUBINE IODIDE, METOCURINE IODIDENEBCIN, TOBRMIYCIN SULFATENEOMYCIN SULFATE, NEOMYCIN SULFATENEOTRIZINE, TRISULFAPYRIMIDINESNOVRAD, LEVOPROPOXYPHENE NAPSYLATEONCOVIN, VINCRISTINE SULFATEPAGITANE HCL, CYCRIMINE HYDROCHLORIDEPENICILLIN G POTASSIUM, PENICILLIN G POTASSIUMPOTASSIUM CHLORIDE, POTASSIUM CHLORIDEPROGESTEROI~E, PROGESTERONEPROPYLTHIOURACIL, PROPYLTHIOURACILPROTAMINE SULFATE, PROTAMINE SULFATEQUINIDINE GLUCONATE, QUINIDINE GLUCONATEQUItUDINE SULFATE, QUINIDINE SULFATESANDRIL, RESERPINESECONAL SODIUtl, Sa::COBARBITAL SODIUMSEROMYCIN, CYCLOSERINESTREPTOMYCIN SULFATE, -STREPTOMYCIN SULFATESULFADIAZINE, SULFADIAZINESULFAPYRIDINE, SULFAPYRIDINESULFONAtlIDES DUPLEX, SULFADIAZINETAPAZOLE, METHIMAZOLETESTOSTERONE PROPIONATE, TeSTOSTERONE PROPIONATETUBOCURARINE CHLORIDE, TUBOCURARINE CHLORIDETYLOSTERONE, DIETHYLSTILBESTROLV-CILLIN, PENICILLIN VV-CILLIN K, PENICILLIN V POTASSIUMVANCOCIN HCL, VANCOMYCIN HYDROCHLORIDEVELBAN, VI~~LASTINE SULFATEELKI:HS-SIHH/AHROBI:HSCHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATECHLORPROMAZINE HCL, CHLORPROMAZINE HYDROCHLORIDECYANOCOBALAMIN, CYANOCOBALAMINDEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATEDIGOXIN. DIGOXINDIMENHYDRINATE, DIMEh'HYDRINATEDIPHENHYDRAMINE HCL, DIPHENHYDRAMINE HYDROCHLORIDEHEP-LOCK, HEPARIN SODIUMHEPARIN SODIUM, HEPARIN SODIUMHYDROXYZINE HCL, HYDROXYZINE HYDROCHLORIDEISOPROTERENOL HCL, ISOPROTERENOL HYDROCHLORIDELIDOCAINE HCL, LIDOCAINE HYDROCHLORIDELIDOCAINE HCL W/ EPINEPHRINE, EPINEPHRINEMEPERIDINE HCL, MEPERIDINE HYDROCHLORIDEMETARAMINOL BITARTRATE, METARAMINOL BITARTRATEMETHYLPREDNISOLONE, METHYLPREDNISOLONE SODIUM SUCCINATENEOMYCIN SULFATE, NEOMYCIN SULFATEPENTOBARBITAL SODIUM, PENTOBARBITAL SODIUMPHENYTOIN, PHENYTOIN SODIUMPOTASSIUM CHLORIDE, POTASSIUM CHLORIDEPROCAINE HCL, PROCAINE HYDROCHLORIDEPROMETHAZINE HCL, PROMETHAZINE HYDROCHLORIDESECOBARBITAL SODIUM, SECOBARBITAL SODIUMSODIUM SUCCINATE, SODIUM SUCCINATE HEXAHYDRATESOTRADECOL, SODIUM TETRADECYL SULFATETHIAMINE HCL, THIAMINE HYDROCHLORIDEEHDO :mcOXYCODONE 5/APAP 500, ACETAMINOPHENEmlO LABS/DUPOHTACON, VITAMIN A PALMITATECOUMADIN, WARFARIN SODIUMMOBAN, MOLI~~ONE HYDROCHLORIDENARCAN, NALOXONE HYDROCHLORIDENARCAN NEONATAL, NALOXONE HYDROCHLORIDENUBAIN, NALBUPHINE HYDROCHLORIDENUMORPHAN HCL, OXYMORPHONE HYDROCHLORIDEOXYCODONE 2.5/APAP 500, ACETAMINOPHENPERCOCET-5, ACETAI1INOPHENPERCODAN, ASPIRINPERCODAN-DEMI, ASPIRINREMSED, PROMETHAZINE HYDROCHLORIDESYMMETREL, AMANTADINE HYDROCHLORIDETESSA LON, BENZONATATEVALPIN 50, ANISOTROPINE METHYLBROMIDE
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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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DIMENHYDlHNATEAPPROVED PRESCRIPTION
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------"".,APPROVED PRESCRIPTION DRU
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APPROVED ¥RESCRIPTION DRUG PRODUCT
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