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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST78LINDANELOTION; TOPICALGAMEHEAT BARNES-HIND PHARMS 1ZKWELLAT REED & CARNRICK 1ZSHAMPOO; TOPICALGAMEHEAT BARNES-HIND PHARMS 1ZKWELLAT REED & CARNRICK 1ZLIOTHYRONINE SODIUMTABLET; ORALCnOMELSKF LABS EQ 5 UGM BASE * EQ 25 UGM BASE *EQ 50 UGM BASELIOTHYRONINE SODIUM; *MULTIPLE*SEE LEVOTHYROXINE SODIUM; LIOTHYRONINE SODIUMLITHIUM CARBONATECAPSULE; ORALESKALrTHAB SKF LABS 300MGLrTHOHAT~AB ROWELL LABS 300MGPFI-LrTHAS PFIPHARMECS/PFIZER 300MGTABLET; ORALESKALITHAB SKF LABS 300MGLrTHAHEAB DOHE LABS/MILES LABS 300MGL:ITHOTABSAB ROWELL LABS 300MG. TABLET, CONTROLLED RELEASE; ORALLITHOBIOROWELL LABS300MGLITHIUM CITRATESYRUP; ORALLITHONATE-SROWELL LABSLOMUSTINECAPSULE; ORALCEENUBRISTOL LABS IBMLOPERAMIOE HYDROCHLORIDECAPSULE; ORALIHODIUMAA JANSSEN PH ARMAA ORTHO PHARMLORAZEPAMINJECTABLE; INJECTIONATIVANWYETH LABS/AMHOTABLET; ORALATIVANWYETH LABS/AMHOLOXAPINE HYDROCHLORtDEEQ 300MG CARBONATE/5MLlOMG * 40MG * lOOMG2HG2MG2MG/ML * 4MG/ML500 UGM * lMG * 2MG * 4MGCONCENTRATE; ORALLOXITANELEDERLE LABS/AM CYAN EQ 25MG BASE/MLINJECTABLE; INJECTIONLOXITANELEDERLE LABS/AM CYAN EQ 50MG BASE/MLLOXAPINE SUCCINATECAPSULE; ORALLOXITANELEDERLE LABS/AM CYAN EQ 5MG BASE * EQ lOMG BASE *EQ 25MG BASE * EQ 50MG BASE
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST79LOXAPINE SUCCINATETABLET; ORALLOXITANELEDERLE LABS/AM CYAN EQ lOMG BASEEQ 50MG BASELYPRESSINSOLUTION; NASALDIAPIDSANDOZ PHARMSMAFENIDE ACETATECREAM; TOPICALSULFAMYLONWINTHROP L/STERLING185 UGM/MLEQ 85MG BASE/GM* EQ 25MG BASE *MAGNESIUM ACETATE TETRAHYDRATEi *MULTIPLE*SEE DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUMACETATE; SODIUM CHLORIDEMAGNESIUM ACETATE; *MULTIPLE*SEE AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID;POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDESEE AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE;SOD IUM CH LOR 10 ESEE DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUMCHLORIDEMAGNESIUM CHLORIDE HEXAHYDRATEi *MULTIPLE*SEE AMINO ACIDS; MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUMACETATE; POTASSIUM CHLORIDE; SODIUM ACETATESEE AMINO ACIDS; MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUMPHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDEMAGNESIUM CHLORIDE; *MULTIPLE*SEE AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE,DIBASIC; SODIUM CHLORIDEMAGNESIUM CHLORIDE; *MULTIPLE*SEE AMINO ACIDSj MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE,DIBASIC; SODIUM CHLORIDESEE CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDEjPOTASSIUM CHLORIDEj SODIUM ACETATE; SODIUM CHLORIDE;SODIUM LACTATESEE CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUMCHLORIDE; SODIUM LACTATESEE CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUMCHLORIDEj SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATESEE DEXTROSEj MAGNESIUM CHLORIDEj POTASSIUM CHLORIDEjPOTASSIUM PHOSPHATE, MONOBASICj SODIUM CHLORIDE; SODIUMLACTATESEE DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUMACETATEj SODIUM CHLORIDE; SODIUM GLUCONATEMAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUMCHLORIDE; SODIUM GLUCONATEINJECTABLE; INJECTIONNORMOSOL-R IN PLASTIC CONTAINERABBOTT LABS'14MG/IOOML;37MG/IOOMLi222MG/IOOMLi526MG/IOOML;502MG/IOOMLPLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINERTRAVENOL LABS 30MG/lOOMLi37MG/IOOML;368MG/IOOML;526MG/IOOMLi502MG/IOOMLSOLUTION; IRRIGATIONPHYSIOSOL IN PLASTIC CONTAINERABBOTT LABS14MG/IOOML;37MG/IOOMLi222MG/lOOMLi526MG/IOOMLi502MG/lOOMLMAGNESIUM METRIZOAT~;*MULTIPLE*SEE CALCIUM METRIZOATEi MAGNESIUM METRIZOATE; MEGLUMINEMETRIZOATE; SODIUM METRIZOATEMANNITOLINJECTABLE; INJECTIONMANNUOlAP INT'L MEDICATION SYS 12.5GM/50MlAP INVENEX PHARMS/MOGUL 12.5GM/50MlAP LYPHO-MED12.5GM/SOMl
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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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oAPPROVED PRESCRIPTION DRUG PRODUCT
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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