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

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APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX1** A **A-H RADIOPHAI?HSA-N STANNOUS AGGREGATED ALBUMIN, TECHNETIUM, TC-99M, ALBUMINAGGREGATED KITABBOTT LABSA-HYDROCORT, HYDROCORTISONE SODIUM SUCCINATEA-~lETHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATEA-POXIDE, CHLORDIAZEPOXIDE HYDROCHLORIDEACETIC ACID 0.25/. IN PLASTIC CONTAINER, ACETIC ACID, GLACIALALCOHOL 5/. IN D5-W, ALCOHOLAMINOSYN, AMINO ACIDSAMINOSYN lOX, AMINO ACIDSAMINOSYN 5/., AMINO ACIDSAMINOSYN 7/., A~lINO ACIDSAMINOSYN 7/. W/ ELECTROLYTES, AMINO ACIDSAMINOSYN 8.5/., AMINO ACIDSAr1INOSYN 8. 5/. W/ ELECTROLYTES, AMINO ACIDSAMNONIUM CHLORIDE, AM~10NIUM CHLORIDEAZENE, CLORAZEPATE MONO POTASSIUMBUPIVACAINE HCL, BUPIVACAINE HYDROCHLORIDECALCIUM GLUCEPTATE, CALCIUM GLUCEPTATECYLERT, PEMOLINEDEPAKENE, VALPROATE SODIUMDEPAKEt~E, VALPROIC ACIDDESOXYN, METHAMPHETAMINE HYDROCHLORIDEDEXTROSE lOX IN WATER IN PLASTIC CONTAINER, DEXTROSEDEXTROSE 2.5X AND SODIUM CHLORIDE 0.45X IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 3.3X AND SODIUM CHLORIDE 0.3X IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 5Y. AND POTASSIUM CHLORIDE 0.15/. IN PLASTICCONTAINER, DEXTROSEDEXTROSE 5Y. AND POTASSIUM CHLORIDE 0.3X IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 5Y. AND SODIUM CHLORIDE 0.225X IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 5/. AND SODIUM CHLORIDE 0.31. IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 5Y. AND SODIUM CHLORIDE 0.45/. IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 51. AND SODIUM CHLORIDE 0.91. IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 51. IN LACTATED RINGER'S IN PLASTIC CONTAINER,CALCIUM CHLORIDEDEXTROSE 5Y. IN PLASTIC COtITAINER, DEXTROSEDEXTROSE 5Y. IN RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDEDEXTROSE 51., SODIUM CHLORIDE 0.225X AND POTASSIUM CHLORIDE0.15X, DEXTROSEDEXTROSE 51., SODIUM CHLORIDE 0.451. AND POTASSIUM CHLORIDE0.15/., DEXTROSEABBOTT LABSDEXTROSE 51., SODIUM CHLORIDE 0.451. AND POTASSIUM CHLORIDE0.224/" DEXTROSEDEXTROSE 51., SODIUM CHLORIDE 0.45X AND POTASSIUM CHLORIDE0.3X, DEXTROSEDIASONE SODIUM, SULFOXONE SODIUMDICUMAROL, BISHYDROXYCOUMARINE.E.S., ERYTHROMYCIN ETHYLSUCCINATEE.E.S. 200, ERYTHROMYCIN ETHYLSUCCINATEE.E.S. 400, ERYTHROMYCIN ETHYLSUCCINATEEND RATE , EDETATE DISODIUMENDURON, METHYCLOTHIAZIDEENDURONYL, DESERPIDINEENDURONYL FORTE, DESERPIDINEERYTHROCIN LACTOBIONATE, ERYTHROMYCIN LACTOBIONATEERYTHROCIN STEARATE, ERYTHROMYCIN STEARATEERYTHROMYCIN, ERYTHROMYCINEUTONYL, PARGYLINE HYDROCHLORIDEEUTRON, METHYCLOTHIAZIDEGEMONIL, METHARBITALGLOFIL-125, IOTHALAMATE SODIUM, 1-125GLYCINE 1.51. IN PLASTIC CONTAINER, AMINOACETIC ACIDHALOTHANE, HALOTHANEHARHONYL, DESERPIDINEHEPARIN LOCK FLUSH, HEPARIN SODIUMHYDROXYZINE HCL, HYDROXYZINE HYDROCHLORIDEISOPROTERENOL HCL, ISOPROTERENOL HYDROCHLORIDEJANIMINE, IMIPRAMINE HYDROCHLORIDEK-TAB, POTASSIUM CHLORIDELACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDELIDOCAINE HCL, LIDOCAINE HYDROCHLORIDELIDOCAINE HCL W/ DEXTROSE, DEXTROSELIDOCAINE HCL W/ EPINEPHRINE, EPINEPHRINELIPOSYN lOX, SAFFLOWER OILLTA II KIT, LIDOCAINE HYDROCHLORIDEMANNITOL 101., MANNITOLMANNITOL 15X, MANNITOLMANNITOL 201., MANNITOLMANNITOL 5/-, MANNITOLNEMBUTAL, PENTOBARBITALNEM8UTAL SODIUM, PENTOBARBITAL SODIUMNORISODRINE, ISOPROTERENOL SULFATENORISODRINE AEROTROL, ISOPROTERENOL HYDROCHLORIDENOR~IOSOL-M AND DEXTROSE 57. IN PLASTIC CONTAINER, DEXTROSENORMOSOL-R AND DEXTROSE 57. IN PLASTIC CONTAINER, DEXTROSENORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDEOGEN, PIPERAZINE ESTRONE SULFATEORETIC, HYDROCHLOROTHIAZIDEORETICYL FORTE, DESERPIDINEORETICYL 25, DESERPIDINEORETICYL 50, DESERPIDINEPANHEPRIN, HEPARIN SODIUM
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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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-_.'PRESCRIPTION DRUG PRODUCTS DEEM
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PRESCRIPTION DRUG PRObUCTS DEEMED A
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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