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

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APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX26PA~KE-DAV:!S/W-LERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATEESTROVIS. QUINESTROLEUTHROID-0.5. LEVOTHYROXINE SODIUMEUTHROID-1, LEVOTHYROXINE SODIUMEUTHROID-2, LEVOTHYROXINE SODIUMEUTHROID-3, LEVOTHYROXINE SODIUMHEPARIN LOCK FLUSH, HEPARIN SODIUMHEPARIN SODIUM, HEPARIN SODIUMHUMATIN, PAROtIOMYC;rN SULFATEISOETHARINE HCL, ISOETHARINE HYDROCHLORIDEISOPROTERENOL HCL, ISOPROTERENOL HYDROCHLORIDEKETALAR, KETAMINE HYDROCHLORIDEMECLOMEN, MECLOFENA11ATE SODIUMMEPERIDINE HCL, MEPERIDINE HYDROCHLORIDEMEPROBAMATE, MEPROBAMATEMILONTIN, PHENSUXIMIDENARDIL, PHENELZINE SULFATENICONYL, ISONIAZIDNOR LUlATE, NORETHINDRONE ACETATENORLUTIN, NORETHINDRONEOPHTHOCHLOR, CHLORAtlPHENICOLOXLOPAR, OXYTETRACYCLINE HYDROCHLORIDEPARACORT, PREDNISONEPAR EST -200, METHAQUALONE HYDROCHLORIDEPAREST-400, tlETliAQUALONE HYDROCHLORIDEPARSIDOL, ETHOPROPAZINE HYDROCHLORIDEPENAPAR-VK, PENICILLIN V POTASSIUMPENICILLIN G POTASSIUM, PENICILLIN G POTASSIUMPENICILLIN G PROCAINE, PENICILLIN G PROCAINEPITRESSIN TANNATE, VASOPRESSIN TANNATEPONSlEL, MEFENAMIC ACID~OVAN, PYRVINIUM PAMOATEPR'E-SATE, CHLORPHENTERMINE HYDROCHLORIDEPROCAINAMIDE HCL, PROCAINAMIDE HYDROCHLORIDEPROCAN, PROCAINAtuDE HYDROCHLORIDEPROLOID, THYROGLOBULINPROPOXYPHENE CmlPOUND 6S, ASPIRINPROPOXYPHENE HCL 6S, PROPOXYPHENE HYDROCHLORIDEPROPYLTHIOURACIL, PROPYLTHIOURACILQUINIDINE SULFATE, QUINIDINE SULFATERENOQUID, SULFACYTINESECOBARBITAL SOOIUtl, SECOBARBITAL SODIUMSINUBID, ACETAMINOPHENSODIUtl PENTOBARBITAL, PENTOBARBITAL SODIUMSULFALAR, SULFISOXAZOLESURITAL, THIAMYLAL SODIUMSYTOBEX, CYANOCOBALAMINTEXACORT, HYDROCORTISONETHEELIN, ESTRONETHIAMINE HCL, THIAMINE HYDROCHLORIDETOLBUTAMIDE, TOLBUTAMIDEF'AP.KE':-DAVIS/W-LUTIBID, OXOLINIC ACIDUTICORT. BETAMETHASONE BENZOATEUTIMOX, AI10XICILLIN TRIHYDRATEVERSTRAN, PRAZEPAMVIRA-A, VIDARABINEVIRA-A, VIDARABINE MONOHYDRATEZARONTIN, ETHOSUXIMIDEPAUL B ELDERBENOQUIN, MONOBENZONEELDECORT, HYDROCORTISONEOXSORALEN, METHOXSALENQUAD-RAMOID, TRISULFAPYRIMIDINESQUADETTS, TRISULFAPYRIMIDINESTRISORALEN, TRIOXSALENJ:EHNWAlTADAPIN, DOXEPIN HYDROCHLORIDEBIPHETAMINE 12.S, AMPHETAMINE RESIN COMPLEXBIPHETAMINE 20, AMPHETAMINE RESIN COtlPLEXBIPHETAMINE 7.S, AMPHETAMINE RESIN COMPLEXIONAMIN-1S, PHENTERMINE RESIN COMPLEXIONAMIN-30, PHENTERMINE RESIN COMPLEXNESACAINE, CHLOROPROCAINE HYDROCHLORIDENESACAINE CE, CHLOROPROCAINE HYDROCHLORIDEZAROXOLYN, METOLAZONEPFAfolST!E':t1L LABSXYLO-PFAN, XYLOSE, D-I'F:!:rli~RMECS/PF:tZF.RCDRTRIL, HYDROCORTISONEPFI-LITH, LITliIUH CARBONATESTERANE, PREDNISOLONETETRACYN, TETRACYCLINETElRACYN, TETRACYCLINE HYDROCHLORIDELABSBACITRACIN, BACITRACINCORTRIL, HYDROCORTISONECORTRIL, HYDROCORTISONE ACETATEDARICON, OXYPHENCYCLIMINE HYDROCHLORIDEDIABHlESE, CHLORPROPAMIDEFOVANE, BENZTHIAZIDEMINI PRESS, PRAZOSIN HYDROCHLORIDEMINIZIDE, POLYTHIAZIDEHITHRACIN, HITHRAHYCINHODERIL, RESCINNAMINENEOBIOTIC, NEOMYCIN SULFATENEOtlYCIN SULFATE, NEOMYCIN SULFATEPENICILLIN G POTASSIUH, PENICILLIN G POTASSIUMPF:tZE~
APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX27PFIZE~LA~SPENICILLIN G PROCAINE, PENICIllIN G PROCAINEPERMAPEN, PENICILLIN G BENZATHINEPFIZER-E, . ERYTHRmlYCIN STEARATEPFIZERPEN, PENICILLIN G POTASSIUMPFIZER PEN G, PENICILLIN G POTASSIUMPFIZERPEN VK, PENICILLIN V POTASSIUMPFIZERPEN-A, AMPICILLIN/AMPICILLIN TRIHYDRATEPFIZERPEN-AS, PENICILLIN G PROCAINEPOLytlIXIN B SULFATE, POLYMYXIN B SULFATERENESE, POLYTHIAZIDERENESE-R, POlYTHIAZIDESINEQUAN, DOXEPIN HYDROCHLORIDESTERANE, PREDNISOLONE ACETATESTREPTOMYCIN SULFATE, STREPTOMYCIN SULFATETERRAt1YCIN, LIDOCAINE HYDROCHLORIDETERRAMYCIN, OXYTETRACYCLINETERRAMYCIN, OXYTETRACYCLINE CALCIUMTERRAMYCIN, OXYTETRACYCLINE HYDROCHLORIDETERRAMYCIN W/ POLYMYXIN, OXYTETRACYCLINE HYDROCHLORIDETERRAMYCIN W/ POLYMYXIN B SULFATE, OXYTETRACYCLINEHYDROCHLORIDETERRAMYCIN-POLYMYXIN, OXYTETRACYCLINE HYDROCHLORIDETETRACYN, TETRACYCLINE HYDROCHLORIDEVANSIl, OXAMNIQUINEVIBRA-TABS, DOXYCYCLINE HYClATEVIBRAMYCIN, DOXYCYCLINE CALCIUMVIBRAMYCIN, DOXYCYCLINE HYClATEVIBRAMYCIN, DOXYCYCLINE ~fONOHYDRATEVIOCIN SULFATE, VIOMYCIN SULFATEVISTARIL, HYDROXYZINE HYDROCHLORIDEVISTARIl, HYDROXYZINE PAMOATEPHARM ASS~CT.ATESDERM-A-eAPS, VITAMIN A PALMITATEH-CORT, HYDROCORTISONETHEOPHYl~INE, THEOPHYllINEPHMmA-TEKBACI-RX, BACITRACINHYDROCORTISONE, HYDROCORTISONEHYDROCORTISmlE ACETATE, HYDROCORTISONE ACETATENEO-RX, NEmlYCIN SULFATEPOlY-RX, POLYMYXIN B SULFATEZIBA-RX, BACITRACIN ZINCF'HARI'!ACAF'SVITAMIN A, VITAMIN AVITAMIN A, VITAMIN A PALMITATEVITAMIN A PALMITATE, VITAMIN A PALMITATEVITAMIN D, ERGOCALCIFEROL,PHAl
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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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