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

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ORETICYL FORTE, DESERPIDINEORETICYL 25, DESERPIDINEORETICYL 50, DESERPIDINEORETON, METHYLTESTOSTERONEORETON, TESTOSTERONEORETON METHYL, METHYLTESTOSTERONEORGATRAX, HYDROXYZINE HYDROCHLORIDEORINASE, TOLBUTAMIDEORINASE, TOLBUTAMIDE SODIUMORLEX, ACETIC ACID, GLACIALORLEX HC, ACETIC ACID, GLACIALORTHO-NOVUM 1/35-21, ETHINYL ESTRADIOLORTHO-NOVUM 1/3S-28, ETHINYL ESTRADIOLORTHO-NOVUM 1/50 21, MESTRANOLORTHO-NOVUM 1/S0 28, MESTRANOLORTHO-NOVUM 1/80 21, MESTRANOLORTHO-NOVUM 10-21, MESTRANOLORTHO-NOVUM 2-21,MESTRANOLORTHO-NOVUM 1/80 28, MESTRANOLOSMITROL lOr. IN WATER. MANNITOLOSMITROL lOr. IN WATER IN PLASTIC CONTAINER, MANNITOLOSMITROL lSr. IN WATER, MA~~ITOLOSMITROL lSr. IN WATER IN PLASTIC CONTAINER, MANNITOLOSMITROL 20r. IN WATER, MANNITOLOSMITROL 20r. IN WATER IN PLASTIC CONTAINER, MANNITOLOSMITROL SF. IN WATER, MANNITOLOSMITROL SF. IN WATER IN PLASTIC CONTAINER, MANNITOLOSTEOLITE, TECHNETIUM, TC-99M, MEDRONATE KITOSTEOSCAN, TECHNETIL~, TC-99M, ETIDRONATE KITOTOBIONE, HYDROCORTISONEOTRIVIN, XYLOMETAZOLINE HYDROCHLORIDEOVCON-3S, ETHINYL ESTRADIOLOVCON-50, ETHINYL ESTRADIOLOVRAL, ETHINYL ESTRADIOLOVRAL-28, ETHINYL ESTRADIOLOVRAL-28 AIm FERROUS FUMARATE, ETHINYL ESTRADIOLOVRETTE, NORGESTRELOVULEN, ETHYNODIOL DIACETATEOVULEN-21, ETHYNODIOL DIACETATEOYULEN-28, ETHYNODIOL DIACETATEOXACILLIN SODIUM, OXACILLIN SODIUM MONOHYDRATEOXLOPAR, OXYTETRACYCLINE HYDROCHLORIDEOXSORALEN, METHOXSALENOXY-KESSO-TETRA, OXYTETRACYCLINE HYDROCHLORIDEOXYCODONE HCL AND ACETAMINOPHEN, ACETAMINOPHENOXYCODONE 2.S/APAP SOO, ACETAMINOPHENOXYCODONE S/APAP SOO, ACETAMINOPHENOXYLONE, FLUOROMETHOLONEOXYTETRACYCLINE HCL, OXYTETRACYCLINE HYDROCHLORIDEOXYTOCIN, OXYTOCIN** P **P.A.S. SODIUM, SODIUM AMINOSALICYLATEAPPROVED PRESCRIPTION DRUG PRODUCTSTRADE NAME INDEXPAGITANE HCL, CYCRIMINE HYDROCHLORIDEPAMELOR, NORTRIPTYLINE HYDROCHLORIDEPAMINE, METHSCOPOLAMINE BROMIDEPAN-TRACE, PREDNISONEPANHEPRIN, HEPARIN SODIUMPANMYCIN, TETRACYCLINEPANl1YCIN, TETRACYCLINE HYDROCHLORIDEPANTOPAQUE, IOPHENDYLATEPANWARFIN, WARFARIN SODIUMPARACORT, PREDNISONEPARADIONE, PARAMETHADIONEPARAFLEX, CHLORZOXAZONEPARASAL, AMItIOSALICYLIC ACIDPARASAL SODIUM, SODIUM AMINOSALICYLATEPAREDRINE, HYDROXYAMPHETAMINE HYDROBROMIDEPAREST-200, METHAQUALONE HYDROCHLORIDEPAREST-400, METHAQUALONE HYDROCHLORIDEPARLODEL, BRot10CRIPTINE MESYLATEPARSIDOL, ETHOPROPAZINE HYDROCHLORIDEPASKALIUM, POTASSIUH AMINOSALICYLATEPATHILON, TRIDIHEXETHYL CHLORIDEPATHOCIL, DICLOXICILLIN SODIUM MONOHYDRATEPAVULON, PANCURONIUI1 BROMIDEPBZ, TRIPELENNAMINE CITRATEPBZ, TRIPELENNAMINE HYDROCHLORIDEPEDIATRIC L TA KIT, LIDOCAINE HYDROCHLORIDEPEDIAZOLE, ERYTHRot1YCIN ETHYLSUCCINATEPEGANOf~E, ETHOTOIHPEN-VEE K, PENICILLIN V POTASSIUMPENAPAR-VK, PENICILLIN V POTASSIUMPEN3RITIN, AI1PICILLIN/AMPICILLIN TRIHYDRATEPENBRITIN-S, AMPICILLIN SODIUMPENICILLIN G POTASSIUH, PENICILLIN G POTASSIUMPENICILLIN G PROCAINE, PENICILLIN G PROCAINEPENICILLIN G SODIUM, PENICILLIN G SODIUMPENICILLIN V POTASSIUM, PENICILLIN V POTASSIUMPENICILLIN YK, PENICILLIN V POTASSIUMPENSYN, AMPICILLIN/AMPICILLIN TRIHYDRATEPENTHRANE, METHOXYFLURANEPEtlTIDS '200', PENICILLIN G POTASSIUMPENTIDS '250', PENICILLIN G POTASSIUMPENTIDS '400', PENICILLIN G POTASSIUMPENTIDS 'SOO', PENICILLIN G POTASSIUMPENTOBARBITAL SODIUM, PEtHOBARBITAL SODIUMPENTOTHAL, THIOPENTAL SODIUMPEPTAVLON, PENTAGASTRINPERCHLORACAP, POTASSIUM PERCHLORATEPERCOCET-S, ACETAMINOPHENPERCODAN. ASPIRINPERCODAN-DEMI, ASPIRINPERCORTEN, DESOXYCORTICOSTERONE ACETATE14
PERCORTEN PIVALATE, DESOXYCORTICOSTERONE PIVALATEPERIACTIN, CYPROHEPTADINE HYDROCHLORIDEPERHAPEN, PENICILLIN G BENZATHINEPERMITIL, FLUPHENAZINE HYDROCHLORIDEPERTOFRANE, DESIPRAHINE HYDROCHLORIDEPFI-LITH, LITHIUM CARBONATEPFIZER-E, ERYTHROMYCIN STEARATEPHZERPEN, PENICILLIN G POTASSIUMPFIZER PEN G, PENICILLIN G POTASSIUMPFIZERPEN VK, PENICILLIN V POTASSIUMPFIZERPEN-A, AMPICILLIN/AMPICILLIN TRIHYDRATEPFIZERPEN-AS, PENICILLIN G PROCAINEPHENAPHEN 14/ CODEINE NO. 2, ACETA~lINOPHENPHENAPHEN 14/ CODEINE NO.3, ACETAMINOPHENPHENAPHEN 14/ CODEINE NO.4, ACETAMINOPHENPHENAPHEN-650 14/ CODEINE, j.CETAMINOPHENPHENAZINE, PHE~~IMETRAZINE TARTRATEPHENAZINE-35, PHENDINETRAZINE TARTRATEPHENCEN-50, PROMETHAZINE HYDROCHLORIDEPHENDItlETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATEPHENERGAN, PROMETHAZINE HYDROCHLORIDEPHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDEPHENETRON, CHLORPHENIRAMINE MALEATEPHENOXENE, CHLORPHENOXAMINE HYDROCHLORIDEPHENTERMINE HCL, PHENTERMINE HYDROCHLORIDEPHENURONE, PHENACEMIDEPHENY-PAS-TEBAMIN, PHENYL AMINOSALICYLATEPHENYLBUTAZONE, PHENYLBUTAZONEPHENYTOIN, PHENYTOIN SODIUtlPHENYTOIN SODIUM, PHENYTOIN SODIL~PHENZINE, PHENDIMETRAZINE TARTRATEPHISO-SCRUB, HEXACHLOROPHENEPHISOHEX, HEXACHLOROPHENEPHOSPHOCOL P 32, CHROMIC PHOSPHATE, P-32PHOSPHO LINE IODIDE, ECHOTHIOPHATE IODIDEPHOSPHOTEC, TECHNETIUM, TC-99M, PYROPHOSPHATE KITPHOSPHOTOPE, SODIUM PHOSPHATE, P-32PHYLLOCONTIN, AMINOPHYLLINEPHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDEPHYTONADIONE, PHYTONADIONEPIPERAZINE CITRATE, PIPERAZINE CITRATEPITRESSIN TANNATE, VASOPRESSIN TAt-INATEPLACIDYL, ETHCHLORVYNOLPLAQUENIL, HYDROXYCHLOROQUINE SULFATEPLASMA-LYTE IN PLASTIC CONTAINER, CALCIUM CHLORIDEPLASHA-LYTE M AND DEXTROSE 57. IN PLASTIC CONTAINER, CALCIUMCHLORIDEPLASMA-LYTE 148 AND DEXTROSE 57. IN PLASTIC CONTAINER, DEXTROSEPLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, MAGNESIUMCHLORIDEPLASMA-LYTE 56 AND DEXTROSE 57. IN PLASTIC CONTAINER, DEXTROSEAPPROVED PRESCRIPTION DRUG PRODUCTSTRADE NAME INDEXPLATINOL, CISPLATINPLEGINE, PHENDIMETRAZINE TARTRATEPMB 200, ESTROGENS, CONJUGATEDPMB 400, ESTROGENS, CONJUGATEDPOLY-RX, POLYMYXIN B SULFATEPOLYCILLIN, AHPICILLIN/AtlPICILLIN TRIHYDRATEPOLYCILLIN-N, AHPICILLIN SODIUMPOLYCILLIH-PRB, AMPICILLIN TRIHYDRATEPOLYMIXIN B SULFATE, POLYMYXIN B SULFATEPOLYI10X, AMOXICILLIN TRIHYDRATEPOLYSPECTRIN, NEOMYCIN SULFATEPOLYSPECTRIN S.O.P., BACITRACIN ZINCPOLYSPORIN, BACITRACIN ZINCPOND IN IN , FENFLURAMINE HYDROCHLORIDEPONSTEL, MEfENAHIC ACID '?POTASSIUM AHINOSALICYLATE, POTASSIUM AMINOSALICYLATEPOTASSIUM CHLORIDE, POTASSIUM CHLORIDEPOVAN,' PYRVINIUM PA1':OATE "PRAMOSONE, HYDROCORTISONE ACETATEPRANTAL, DIPHEMANIL METHYLSULFATEPRE-OP, HEXACHLOROPHENE .PRE-PEN, BENZYL PENICILLOYL~POLYLYSINEPRE-SATE, CHLORPHENTERMINE HYDROCHLORIDEPRED FORTE, PREDNISOLONE ACETATEPRED MILD, PREDNISOLm~E ACETATEPREDNICEN-M, PREDNISONEPREDNISOLONE, PREDNISOLONEPREDNISOLONE ACETATE, PREDNISOLONE ACETATEPREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATEfiREDNISOLONE TERTIARY BUTYL ACETATE, PREDNISOLONE TEBUTATEPREDNISONE, PREDNISONE .PREGNYL, GONADOTROPIN. CHORIONICPRELUOIN, PHENMETRAZINE HYDROCHLORIDEPREMARIN; ESTROGENS, CONJUGATEDPRIt1AQUINE,PRIHAQUINE PHOSPHATEPRIMIDONE,PRIMIDDNEPRINCIPEN i 125'. AMPICILLIN/AMPICILLIN TRIHYDRATEPRINCIPEN '250', AMPICILLIN/AMPICILLIN T.RIHYD,RATEPRINCIPEN '500', AMpICILLIN/AMPICILLIN TR1:HYDRATEPRINCIPEN 14/ PROBENECID, AMPICILLItl). TRIHYDRATEPRO-BANTHINE, PRopANTHELINE BROMIDE"PROAQUA, BENZTHIAZIDEPROBALAN, PROBENECIO'PROBeN-C, COLCHICINEPROBENECID, PROBENECID .PROBENECID AND COLCHICINE, COLCHICINE"";";!'PR08ENECID 14/ COLCHICINE, COLCHICINEPROCAINAtlIDE HCL, PRDCAINAMIDE HYDROCHLORIDEPROCAINE HCL, PROCAINE HYDROCHLORIDEPROCAINE HCL 14/ EPINEPHRINE, EPINEPHRINEPROCAN, PROCAINAMIDE HYDROCHLORIDE15
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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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