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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST108POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINEPRAZEPAMINJECTABLE; INJECTIONTHAM-EABBOTT LABS370 UGM/ML;1.75MG/ML;36MG/MLTABLET; ORALVERSTRANPARKE-DAVIS/IoI-L10MGPOTASSIUM PERCHLORATEPRAZOSIN HYDROCHLORIDECAPSULE; ORALPERCHLORACAPMALLINCKRODT200MGCAPSULE; ORALMINI PRESSPFIZER LABSIMG * 2MG * 5MGPOTASSIUM PHOSPHATE, DIBASIC; *MULTIPLE*SEE AMINO ACIDS; MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUMPHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDESEE AMINO ACIDS; MAGNESIUM CHLORIDEj POTASSIUM PHOSPHATE,DIBASIC; SODIUM CHLORIDEPOTASSIUM PHOSPHATE, MONOBASIC; *MULTIPLE*SEE DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE;POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUMLACTATEPRALIDOXIME CHLORIDEINJECTABLE; INJECTIONPROTOPAM CHLORIDEAYERST LABS/AMHOTABLET; ORALPROTO PAM CHLORIDEAYERST LABS/AMHOIGM/VIAL500MGPRAMOXINE HYDROCHLORIDE; *MULTIPLE*SEE HYDROCORTISONE ACETATEj PRAMOXINE HYDROCHLORIDEPRAZEPAMCAPSULE; ORALCENTRAXPARKE-DAVIS/IoI-L5MG * 10MGPRAZOSIN HYDROCHLORIDE; *HULTIPLE*SEE POLYTHIAZIDEj PRAZOSIN HYDROCHLORIDEPREDNISOLONETABLET; ORALCORTALONEBX HALSEY DRUG IHG * 2.5MG * 5MGDElTA-CORTEFBX UPJOHN 5MGFERNISOLONE-PBX FERNDALE LABS 5HGPREDNISOLONEBX BARR LABS 5HGBX BELL PHARMACAL 5HGBX CHElSEA LABS 5MGBX CM BUNDY 5HGBX CORD LABS 5MGBX DANBURY PHARMACAL 5MGBX FEDERAL PHARMACAL 5MGBX GENERIC PHARM/IVY 5HGBX HEATHER DRUG 5MGBX ICN PHARHS 5MGBX INWOOD LABS/FOREST 5HGBX KETCHUM LABS 5MGBX LANNETT 5MGBX LEMMON PHARHACAL 5MGBX HK LABS 2.5MG * 5HGBX MYlAN PHARMS 5MGBX PANRAY/ORMONT DRUG IMG * 5HGBX PHILIPS ROXANE LABS 5MG
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST109PREDNISOLONETABLET; ORALPREDNISOLONEBX PHOENIX LABS 5MGBX PREMO PHARM LABS 5MGBXPRIVATE FORMULATIONS 5MGBX PUREPAC PHARM 5MGBX REXALL DRUG 5MGBX RICHLYN LABS 5MGBX SPERTI DRUG PRODS IMG * 2.5MG * 5MGBX STAN LABS PHARM IMG * 2.5MG * 5MGBX TABLICAPS 5MGBX TOWNE PAULSEN 5MGBX WEST -W.A.RD 5MGBX ZENITH LABS 5MGSTERANEBX PFIPHARMECS/PFIZER 5MGPREDNISOLONE ACETATEINJECTABLE; INJECTIONFERNISOLONEBP FERNDALE LABS 25MG/MLMETICORTELONE ACETATEBP SCHERING 25MG/MLPREDNISOLONE ACETATEBP BEL-MAR LABS 25MG/ML * 50MGIMLBP CARTER-GLOGAU LABS 25MG/ML * 50MG/ML40MG/MLBP CENTRAL PHARMACAL 25MG/ML * 50MGIMLBP D-M PHARMACEUTICALS 25MG/ML * 50MG/MLBP MAURRY BIOLOGICAL' 25MG/ML * 50MG/MLSTERANEBP PFIZER LABS 25MG/MLSUSPENSIONIDROPS; OPHTHALtIICECONOPREDALCON LABS· 0.12570ECOHOPRED PLUSAT ALCON LABS 17.PRED FORTEAT ALLERGAN PHARMS 17.PRED MILDALLERGAN PHARMS 0.1270PREDNISOLONE SODIUM PHOSPHATEINJECTABLE; INJECTIONHYDELTRASOLAP MERCK SHARP & DOHME EQ 20MB PHOSPHATE/MLSOLU-PREDAP CARTER-GLOGAU EQ 20MB PHOSPHATE/MLOINTMENT; OPHTHALMICHYDELTRASOLMERCK SHARP & OOHMEEQ 0.2570 PHOSPHATESOLUTION/DROPS; OPHTHALMICHYDELTRASOLAT MERCK SHARP & OOHME EQ 0.5? PHOSPHATEItfFLAMAS:EAT SMITH MILLER PATCH EQ 0.1? BASEItfFLAMASE FORTEAT SMITH MILLER PATCH EQ 0.8? BASEMETRETO"AT SCHERING EQ 0.5? PHOSPHATEPREDHISOLOHE SODIUM PHOSPHATEBARNES-HIND PHARMS IXAT MAURRY BIOLOGICAL Eq 0.17. BASE * Eq 0.87. BASEUNIMINBARNES-HIND PHARMS 0.12570PREDNISOLONE TEBUTATEINJECTABLE; INJECTIONHYDELTRA TBABP MERCK SHARP & DOHME 20MG/MLPREDNISOLONE TERTIARY BUTYL ACETATEBP CARTER-GLOGAU LABS 20MG/MLPREDNISOLONE; *MULTIPLE*SEE ALUMINUM CHLORHYDROXY 'ALLANTIONATE; PREDNISOLONESEE CHLORAMPHENICOL; PREDNISOLONEPREDNISONECAPSULE; ORALPREDNISONERP SCHERER50MG
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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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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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