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

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PROCAPAN, PROCAINAMIDE HYDROCHLORIDEPROCHLORPERAZINE, PROCHLORPERAZINE MALEATEPROCHLORPERAZWE EDISYLATE, PROCHLORPERAZIHE EDISYLATEPROCTOCORT, HYDROCORTISONEPROCTOFOAM HC, HYDROCORTISONE ACETATEPROGESTASERT, PROGESTERONEPROGESTERONE, PROGESTERONEPROGLYCEM, DIAZOXIDEPROKETAZINE, CARPHENAZINE MALEATEPROKLAR, SULFAtlETHIZOLEPROLIXIN, FLUPHENAZINE HYDROCHLORIDEPROLIXIN DECANOATE, FLUPHENAZINE DECANOATEPROLIXIN ENANTHATE, FLUPHENAZINE ENANTHATEPROLOID, THYROGLOBULINPROLOPRIM, TRIMETHOPRIMPROMAZINE HCL, PROMAZINE HYDROCHLORIDEPROMETH, PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HCL, PROMETHAZINE HYDROCHLORIDEPRONESTYL, PROCAINAMIDE HYDROCHLORIDEPROPANTHELINE BROMIDE, PROPANTHELINE BROMIDEPROPARACAINE HCL, PROPARACAINE HYDROCHLORIDEPROPINE, DIPI\lEFRItl HYDROCHLORIDEPROPOXYPHENE CotlPOUND 65, ASPIRINPROPOXYPHENE HCL, PROPOXY.PHENE HYDROCHLORIDEPROPOXYPHENE HCL COMPOUND 65, ASPIRINPROPOXYPHENE HCL WI A.P.C., ASPIRINPROPOXYPHENE HCL WI APAP, ACETAt1INOPHENPROPOXYPHENE HCL 65, PROPOXYPHENE HYDROCHLORIDEPROPYLTHIOURACIL, PROPYLTHIOURACILPROSTAPHLIN, OXACILLIN SODIUM MONOHYDRATEPROSTIGt1IN BROtlIDE, NEOSTIGMINE BROMIDEPROSTIN E2, DINOPROSTONE(pROSTAGLANDIN E-2)PROSTIN F2 ALPHA, DINOPROST TRotlETHAMINEPROSTIN/15M, CARBOPROST TROMETHAMINEPROTAt1INE SULFATE, PROTAMINE SULFATEPROTOPAM CHLORIDE, PRALIDOXIME CHLORIDEPROVAL #3, ACETAMINOPHENPROVERA, tlEDROXYFROGESTERONE ACETATEPULMOLITE, TECHNETIUM, TC-99M, ALBUMIN AGGREGATED KITPURIFIED CORTROPHIN GEL, CORTICOTROPINPURINETHOL, MEgCAPTOPURINEPYOCIDIN, HYDROCORTISONEPYOPEN, CARBENICILLIN DISODIUMPYRAZINAMIDE, PYRAZINAMIDEPYRIDAMAL 100, CHLORPHENIRAMIHE MALEATEPYRIDOXINE HCL, PYRIDOXINE HYDROCHLORIDEPYRILAMINE MALEATE, PYRILAMINE MALEATEPYROLITE, TECHNETIUM, TC-99M, PYRO/TRIMETA PHOSPHATES KIT** Q **APPROVED PRESCRIPTION DRUG PRODUCTSTRADE NAME INDEXQUAD-RAMOID, TRISULFAPYRIMIDINESQUADETTS, TRISUlFAPYRIMIDINESQUARZAN, CLIDINIUM BROMIDEQUELICIN, SUCCINYLCHOLINE CHLORIDEQUESTRAN, CHOLESTYRAMINEQUIDE, PIPERACETAZINEQUINACT, QUINIDINE GLUCONATEQUINAGLUTE, QUINIDINE GLUCONATEQUINIDEX, QUINIDWE SULFATEQUINIDINE GLU40NATE, QUINIDINE GLUCONATEQUINIDI)':IE "SULFATE, QUINIDINE SULFATEQUINORA, QUINIDINE SULFATE** R **R-GENE 10, ARGININE HYDROCHLORIDER-P MYCIN, ERYTHROMYCINRADIO~IODINATED (I 125) SERUM ALBUMIN (HUMAN), ALBUMIN,IODINATED, 1-125, SERUMRADIOIODUIATED SERUM ALBUMIN (HUMAN) IHSA I 125, ALBUMIN,IODINATED, 1-125, SERUMRADIOIODINATED SERUM ALBUMIN (HUMAN) IHSA I 131, ALBUMIN,IODINATED, 1-131, SERUMRADIONUCLIDE-LABELED (125 I) FIBRINOGEN (HUMAN) SENSOR,FIBRINOGEN, 1-125RAU-SED, RESERPINERAUDIXIN, RAUWOLFIA SERPENTINARAURINE, RESERPINERAUSERPIN, RAUWOLFIA SERPENTINARAUTENSIN, ALSEROXYLONRAUTOTAL, RAUWOLFIA SERPENTINARAUVAL, RAUWOLFIA SERPENTINARAUWILOID, ALSEROXYLONRAUWOLFIA SERPENTIHA, RAUWOLFIA SERPENTINARAVOCAINE HCL AND NOVOCAIN WI LEVOPHED, LEVARTERENOL BITARTRATERAVOCAINE.HCL AND NOVOCAIN WI NEO-COBEFRIN, LEVONORDEFRINRECTOID, HYDROCORTISONEREDISOL, CYANOCOBALAMINREGITIHE, PHENTOLAMINE HYDROCHLORIDEREGITINE, PHENTOLAMINE MESYLATEREGLAN, METOCLOPRAMIDE HYDROCHLORIDEREGONOL, PYRIDOSTIGMINE· BROMID.EREGROTON, CHLORTHALIDONERELA, CARISOPRODOLRELEFACT TRH, PROTIRELINREMSED, PROMETHAZINE HYDROCHLORIDERENESE, POLYTHIAZIDERENESE-R, POLYTHIAZIDERENO-M-DIP, DIATRIZOATE MEGLUMINERENO-M-30, DIATRIZOATE MEGLUMINERENO-M-60, OIATRIZOATE NEGLUNINEQUAALUOE, METHAQUALONE .----~,..,..~- .. -.- .-,-.::;1'16,i~'f''''~''~'':~';'''~''"";""",,,-::-1'''--,...j'.'"
APPROVED PRESCRIPTION DRUG PRODUCTSTRADE NAME INDEX17RENOGRAFIN-60, DIATRIZOATE MEGLUMINERENOGRAFIN-76, DIATRIZOATE MEGLUMINERENOQUID, SULFACYTINERENOTEC, TECHNETIUM, TC-99H, PENTETATE KITRENOVIST, DIATRIZOATE MEGLUMINERENOVIST II, DIATRIZOATE MEGLUMINERENOVUE-DIP, IODAMIDE MEGLUrUNERENOVUE-65, IODAMIDE MEGLUMINEREPOISE, BUTAPERAZINE.MALEATEREPOSITORY CORTICOTROPIN, CORTICOTROPINREPRO COMPOUND 65, ASPIRINRESECTISOL, MANNITOLRESERPINE, RESERPINERESERPOID, RESERPINERESINE, RESERPINERETET, TETRACYCLINE HYDROCHLORIDERETIN-A, TRETINOINREZIPAS, AMINOSALICYLIC ACID RESIN COMPLEXRIFADIN, RIFAMPINRIFAMATE, ISONIAZIDRIrlACTANE, RIFAtlPINRIMIFON, ISONIAZIDRIMSO-50, DIMETHYL SULFOXIDERINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDERINGER'S SOLUTION IN PLASTIC CONTAINER, CALCIUM CHLORIDERITALIN, METHYlPHENIDATE HYDROCHLORIDEROBAXIN, METHOCARBAMOLROBAXISAL, ASPIRINROBENGATOPE, SODIUM ROSE BENGAL, 1-131ROBII1YCIN, ERYTHROMYCINROBINUL, GL YCOPYRROLATEROBINUL FORTE, GLYCOPYRROLATEROBITET, TETRACYCLINEROBITET, TETRACYCLINE HYDROCHLORIDEROCALTROL, CALCITRIOLRONDONYCIN, METHACYCLINE HYDROCHLORIDERU-HY-T, RAUWOLFIA SERPENTINARUBIVITE, CYANOCOBALAMINRUBRAMIN-PC, CYANOCOBALAMINRUBRATOPE-57, CYANOCOBALAtlIN, CO-57RUBRATOPE-S7 KIT, COBALT CHLORIDE, CO-57RUBRATOPE-60, CYANOCOBALAMIN, CO-60RUBRATOPE-60 KIT, COBALT CHLORIDE, CO-60RUVITE, CYANOCOBALAMIN** S **S.A.S.-500, SULFASALAZINESALPIX, ACETRIZOATE SODIUMSALURON, HYDROFLUtlETHIAZIDESALUTENSIN, HYDROFLUMETHIAZIDESALUTENSIN-DEMI, HYDROFLUMETHIAZIDESANDRIL, RESERPINESANOREX, MAZINDOLSANSERT, METHYSERGIDE MALEATESARISOL NO.1, BUTABARBITAL SODIUMSARISOL NO.2, BUTABARBITAL SODIUMSCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENESECOBARBITAL SODIUM, SECOBARBITAL SODIUMSECONAL SODIUM, SECOBARBITAL SODIUMSEDS-TENS SE, HOMATROPINE METHYLBROMIDESELENIUM SULFIDE, SELENIUM SULFIDESELENOMETHIONINE SE 75, SELENor1ETHIONINE, SE-75SELSUN, SELENIUM SULFIDESEPTI-SOFT, HEXACHLOROPHENESEPTISOL, HEXACHLOROPHENESEPTRA, SULFAMETHOXAZOLESEPTRA DS, SULFAHETHOXAZOLESER-A-GEN, HYDRALAZINE HYDROCHLORIDESER-AP-ES, HYDRALAZINE HYDROCHLORIDESERAX, OXAZEPAMSERENTIl, tlESORIDAZINE BESYlATESEROMYCIN, CYCLOSERINESERPALAN, RESERPINESERPANRAY, RESERPINESERPASIL, RESERPINESERPASIL-APRESOLINE, HYDRALAZINE HYDROCHLORIDESERPASIL-ESIDRIX #1, HY-DROCHLOROTHIAZIDESERPASIL-ESIDRIX #2, HYDROCHLOROTHIAZIDESERPATE, RESERPINESERPIVITE, RESERPINESERVISONE, PREDNISONESETHOTOPE, SELENOtIETHIONINE, SE-75SILVADENE, SILVER SULFADIAZINESINEMET, CARBIDOPASINEQUAN, DOXEPIN HYDROCHLORIDESWOGRAFIN, DIATRIZOATE MEGLUMINESINUBID, ACETAMINOPHENSK-AMITRIPTYLINE, AMITRIPTYLINE HYDROCHLORIDESK-BAMATE, MEPROBAMATESK-DIPHENHYDRAMINE, DIPHEr-..'HYDRAHINE HYDROCHLORIDESK-HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDESK-LYGEN, CHLORDIAZEPOXIDE HYDROCHLORIDESK-PRAMINE, IMIPRAMINE HYDROCHLORIDESK-SOXAZOLE, SULFISOXAZOLESK-TOLBUTAMIDE, TOLBUTAMIDESK-65, PROPOXYPHENE HYDROCHLORIDESK-65 COMPOUND, ASPIRINSKELAXIN, METAXALONESLO-PHYLLiN, THEOPHYLLINESLO-PHYLLIN-80, THEOPHYLLINESLOW-K, POTASSIUM CHLORIDE
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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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'''"APPROVED PRESCRIPTION DRUG PROD
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----..//APPROVED PRESCRIPTION DRUG
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"~''''''-- .APPROVED PRESCRIPTION D
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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