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

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APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX2ABBOTT LABSPANWARFIN, WARFARIN SODIUMPARADIONE, PARAMETHADIONEPEDIATRIC LTA KIT, LIDOCAINE HYDROCHLORIDEPEGAtmNE, ETHOTOINPENTHRANE, METHOXYFLURANEPENTOTHAL, THIOPENTAL SODIUMPHENURONE, PHENACEMIDEPHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDEPLACIDYL, ETHCHLORVYNOLPOTASSIUM CHLORIDE, POTASSIUM CHLORIDEPROCAINE HCL, PROCAINE HYDROCHLORIDEQUELICIN, SUCCINYLCHOLINE CHLORIDERADIONUCLIDE-LABELED (125 I) FIBRINOGEN (HUMAN) SENSOR,FIBRINOGEN, 1-125RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDESELSUN, SELENIUM SULFIDESODIUM CHLORIDE, SODIUM CHLORIDESODIUM CHLORIDE 0.45X IN PLASTIC CONTAINER, SODIUM CHLORIDESODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDESODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER, SODIUMLACTATESORBITOL-MANNITOL, MANNITOLSORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOLSTERILE UREA, L~EASTERILE WATER IN PLASTIC CONTAINER, WATER FOR IRRIGATIONSTERILE WATER IN PLASTIC CONTAINER, WATER, FOR INJECTIONSULFADIAZINE, SULFADIAZINETHAM, TROHETHAMINETHAN-E, POTASSIU~I CHLORIDETHYPINONE, PROTIRELIHTRAL, HEXOCYCLIUH METHYLSULFATETRANXWE, CLORAZEPATE DIPOTASSIUMTRANXENE SO, CLORAZEPATE DIPOTASSIUMTRIDIONE, TRIMETHADIONETUBOCURARINE CHLORIDE, TUBOCURARINE CHLORIDEUREAFHIL, UREAVERCYTE, PIPOBROMANNUCLEARAN-MDP, TECHNETIUM, TC-99M, MEDRONATE KITACKE~~IA"ADRIA LABSADRUCIL, FLUOROURACILAli P.CE!!.tlSDItIETANE, BRmlPHENIRAMINE MALEATEDItIETANE-TEN, BRmlFHENIRAMINE MALEATEDOPRAM, DOXAPRAM HYDROCHLORIDEEXNA, BEHZTHIAZIDEEXNA-R, BENZTHIAZIDEHEPARIN SODIUM, HEPARIN SODIUMAli Rt!B:IHSIHAVATE, IMIPRAMINE HYDROCHLORIDEPHENAPHEN WI CODEINE NO.2, ACETAMINOPHENPHENAPHEN WI CODEINE NO.3, ACETAMINOPHENPHENAPHEN WI CODEINE NO.4, ACETAMINOPHENPHENAPHEN-650 WI CODEINE, ACETAMINOPHENPONDIMIN, FENFLURAMINE HYDROCHLORIDEQUINIDEX, QUINIDINE SULFATEREGLAN, METOCLOPRAMIDE HYDROCHLORIDEREPOISE, BUTAPERAZINE MALEATEROBAXIN, METHOCARBAMOLROSAXISAL, ASPIRINROBIMYCIN, ERYTHROMYCINROBINUL, GLYCDPYRROLATEROBINUL FORTE, GLYCOPYRROLATEROBITET, TETRACYCLINEROBITET, TETRACYCLINE HYDROCHLORIDESKELAXIN, METAXALONESULLA, SULFAMETERTYBATRAN, TYBAMATEALCOlf LABSALCAINE, PROPARACAINE HYDROCHLORIDECETAMIDE, SULFACETAMIDE SODIUMCYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDECYCLOMYDRIL, CYCLOPENTOLATE HYDROCHLORIDEDEHDRID, IDOXU1HDINEECHODIDE, ECHOTHIOPHATE IODIDEECONOCHLOR, CHLORA~IPHENICOLECONOPRED, PREDNISOLONE ACETATEECONOPRED PLUS, PREDNISOLONE ACETATEFLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDEISOPTO CETAMIDE, SULFACETAMIDE SODIUMMAXIDEX, DEXAMETHASONEMAXIDEX, DEXAMETHASONE SODIUM PHOSPHATEMIOSTAT, CARBACHOLMYDRIACYL, TROPICAMIDENAPHCON FORTE, NAPHAZOLINE HYDROCHLORIDENATACYN, NATAMYCINORATROL, DICHLORPHENAMIDESTATROL, NEOMYCIN SULFATEZOLYSE, CHYMOTRYPSINALCON LABS/PRANESTACON, LIDOCAINE HYDROCHLORIDE
APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER IHDEX3ALLERGAH FHARMSALBALON, NAPHAZOLINE HYDROCHLORIDEBLEPH-IO, SULFACETAMIDE SODIUMBLEPH-30, SULFACETAMIDE SODIUMCHLOROPTIC, CHLORAMPHENICOLCHLOROPTIC S.O.P., CHLORAMPHENICOLCHLOROPTIC-P S.O.P., CHLORAMPHENICOLETHAMIDE, ETHOXZOLAMIDEFML, FLUOROMETHOLONEHERPLEX, IDOXURIDINEHMS, MEDRYSONEOPHTHETIC, PROPARACAINE HYDROCHLORIDEPOLYSPECTRIN, NEOMYCIN SULFATEPOLYSPECTRIN S.O.P., BACITRACIN ZINCPRED FORTE, PREDNISOLONE ACETATEPRED MILD, PREDNISOLONE ACETATEPROPINE, DIPIVEFRIN HYDROCHLORIDEALZAOCUSERT PILO-20, PILOCARPINEOCUSERT PILO-40, PILOCARPINEPROGESTASERT, PROGESTERONETRANSDERM-V, SCOPOLAtlINE fiYDROBROMIDEAM I'lctMN/AM HOSPACETIC ACID 0.2SX IN PLASTIC CONTAINER, ACETIC ACID, GLACIALALCOHOL lOX AND DEXTROSE 5X IN DISTILLED WATER, ALCOHOLALCOHOL 5X AND DEXTROSE 5X IN DISTILLED WATER, ALCOHOLAMIHOACETIC ACID l.SX IN PLASTIC CONTAINER, AMINOACETIC ACIDAtlMONIUM CHLORIDE, AMtlONIUM CHLORIDEAtlllotHUM CHLORIDE IN ISOTONIC SODIUM CHLORIDE, AMMONIUMCHLORIDEDEXTROSE ·lOX AND SODIUM CHLORIDE 0.2X IN PLASTIC CONTAINER,DEXTROSEDEXTROSE lOX AND SODIUM CHLORIDE 0.45X IN PLASTIC CONTAINER,DEXTROSEDEXTROSE lOX AND SODIUM CHLORIDE 0.9X IN PLASTIC CONTAINER,DEXTROSEDEXTROSE lOX IN PLASTIC CONTAINER, DEXTROSEDEXTROSE 2.5X A~ID SODIUM CHLORIDE 0.45X IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 2.SX AND SODIUM CHLORIDE 0.9X IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 2.SX IN PLASTIC CONTAINER, DEXTROSEDEXTROSE 5X AND SODIUM CHLORIDE O.llX IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 5X AND SODIUM CHLORIDE 0.2X IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 5X AND SODIUM CHLORIDE 0.33X IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 5X AND SODIUM CHLORIDE 0.4SX IN PLASTIC CONTAINER,DEXTROSEAM r-:OGAIVAM HOSPDEXTROSE SX AND SODIUM CHLORIDE 0.97. IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 5X IN ACETATED RINGER'S IN PLASTIC CONTAINER,CALCIUM CHLORIDEDEXTROSE SX IN LACTATED RINGER'S IN PLASTIC CONTAINER,CALCIUM CHLORIDEDEXTROSE 5X IN PLASTIC CONTAINER, DEXTROSEDEXTROSE 5X IN RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDEDEXTROSE 607., DEXTROSEFREAMINE II 8.SX, AMINO ACIDSFREAMINE III 3X WI ELECTROLYTES, AMINO ACIDSFREAMINE III 8.SX, AMINO ACIDSFREAMINE 8.57., AMINO ACIDSLACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDELIDOCAINE HCL, LIDOCAINE HYDROCHLORIDEMANNITOL lOX, MANNITOLMA~~ITOL lOX WI DEXTROSE 5% IN DISTILLED WATER, DEXTROSEMANNITOL 15%, MANNITOLMANNITOL lSX WI DEXTROSE 5% IN SODIUM CHLORIDE 0.457., DEXTROSEMANNITOL 20%, MANNITOLMANNITOL SX, MANNITOLMANNITOL 5% WI DEXTROSE 5% IN SODIUM CHLORIDE 0.127., DEXTROSEMETARAMINOL BITARTRATE, METARAMINOL BITARTRATENEPHRAllINE 5.47., AMINO ACIDSPOTASSIUM CHLORIDE, POTASSIUM CHLORIDEPROCAINE HCL, PROCAINE HYDROCHLORIDERESECTISOL, MANNITOLRINSER'S SOLUTION IN PLASTIC CONTAINER, CALCIUM CHLORIDESODIUM CHLORIDE, SODIUM CHLORIDESODIUM CHLORIDE IN PLASTIC CONTAINER, SODIUM CHLORIDESODIUM CHLORIDE O.45X IN PLASTIC CONTAINER, SODIUM CHLORIDESODIUM CHLORIDE 0.9X IN PLASTIC CONTAINER, SODIUM CHLORIDESODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER, SODIUMLACTATESORBITOL 3.3X IN PLASTIC CONTAINER, SORBITOLSTERILE WATER IN PLASTIC CONTAINER, WATER FOR IRRIGATIONAMBrx LABS/ORGAHrCSHYDROCORTISONE, HYDROCORTISONENITROFURAZONE, NITROFURAZONEAMER Cp-rT CARE/AH~CBRETYLOL, BRETYLIUM TOSYLATEINTROPIN, DOPAMINE HYDROCHLORIDEINULIN, INULIN
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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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-,----APPROVED PRESCRIPTION DRUG PR
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------"".,APPROVED PRESCRIPTION DRU
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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