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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST96NYSTATINTABLET; VAGINALMYCOSTATJ:HAT ER SQUIBB AND SONS 100~000 UHI:TSHI:LSTATATLEDERLE LABS/AM CYAN 100,000 UHI:TSHYSTATI:HAT CHELSEA LABS 100,000 UHITSAT PREt10 PHARM LABS 100,000 UHITSNYSTATIN; *truLTIPLE*SEE IODOCHLORHYDROXYQUINj NYSTATINORPHENADRINE CITRATEINJECTABLE; INJECTIONNORFLEXRIKER LABS/3MTABLET; ORALNOR FLEXRIKER LABS/3M30MGIMLIOOMGORPHENADRINE CITRATE; *MULTIPLE*SEE ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE; PHENACETINOXACILLIN SODIUM MONOHYDRATEINJECTABLE; INJECTIONBACTOCI:LLAP BEECHAM LABSAPAPAPM!APPROSTAPHLI:HBRISTOL LABSIBMEQ 500~G BASE/VI:AL MEQ lGM BASE/VI:AL MEQ 2GM BASE/VI:AL M EQ 4GM BASE/VI:ALEQ 10GH BASE/VIALEQ 500MG BASE/VI:AL MEq lGM BASE/VIAL MEq 2GM BASE/VI:AL M Eq 4GM BASE/VIALEQ 250MG BASE/VIALPOWDER FOR RECONSTITUTION; ORALOXACILLIH SODIUMAA BIOCRAFT LABS EQ 250MG BASE/5MLPROSTAPHLIHAB BRISTOL LABS/BM Eq 250MG BASE/5MLOXAMNIQUINECAPSULE; ORALVANSILPFIZER LABSOXANDROLONE250MGORPHENADRINE HYDROCHLORIDETABLET; ORALDISIPALRIKER LABS/3MOXACILLIN SODIUM MONOHYDRATE50MGCAPSULE; ORALBACTOCI:LLAB BEECHAM LABSOXACI:llIH SODIUMEQ 250MG BASE M EQ 500MG BASEAB BIOCRAFT LABSPROSTAPHL:tHEq 250MG BASE M Eq 500MG BASEAB BRISTOL LABS/BM EQ 250MG BASE M EQ 500MG BASETABLET; ORALANAVARSEARLE PHARMSOXAZEPAMCAPSULE; ORALSERAXWYETH LABS/AMHOTABLET; ORALSERAXWYETH LABS/AMHO2.5MGIOMG * 15MG * 30MGISMG_~,~~d
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST97OXOLINIC ACIDOXYMORPHONE HYDROCHLORIDETABLET; ORALUTIBIDPARKE-DAVIS/W-L7S0MGINJECTABLE; INJECTIONNUMORPHAN HCLENDO LABS/DUPONTIMG/ML * I.SMG/MLOXTRIPHYlLINEOXYPHENBUTAZONESYRUP; ORALCHOLEDYlPARKE-DAVIS/W-L50MG/SMLTABLET; ORALTANDEARIlGEIGY PHARHSIOOMGTABLET, ENTERIC COATED; ORALCHOLEDYLPARKE-DAVIS/W-L IOOMG * 200MGOXYBUTYNIN CHLORIDEOXYPHENCYCLIHINE HYDROCHLORIDETABLET; ORALDAR ICONPFIZER LABSIOMGSYRUP; ORALDITROPANMARION LABSTABLET; ORALDITROPANMARION LABS5MG/5MLSMGOXYCODONE HYDROCHLORIDE; *MULTIPLE*SEE ACETAMINOPHEN; OXYCODONE HYDROCHLORIDESEE ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE; OXYCODONETEREPHTHALATESEE ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATEOXYCODONE TEREPHTHALATE; *tlUL TIPLE*SEE ACETAHINOPHEN; OXYCODONE HYDROCHLORIDE; OXYCODONETEREPHTHALATESEE ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATEOXYPHENONIUM BROMIDETABLET; ORALANTRENYl BROMIDECIBA PHARMOXYTETRACYCLINETABLET; ORALTERRAMYCINPFIZER LABSOXYTETRACYCLINE CALCIUMSYRUP; ORALTERRAMYCINPFIZER LABSSHG2S0MGEQ 125MG BASE/SMLOXYHETHOLONETABLET; ORALANADROL-SOSYNTEX LABS50HGOXYTETRACYCLINE HYDROCHLORIDECAPSULE; ORALO>CLOPARAS PARKE-DAVIS/W-L EQ 250MG BASE
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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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PERCORTEN PIVALATE, DESOXYCORTICOST
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oAPPROVED PRESCRIPTION DRUG PRODUCT
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APPROVED PRESCRIPTIOH DRUG PRODUCTS
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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