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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST66HYDROCHLOROTHIAZIDE; SPIRONOLACTONETABLET; ORALALDACTAZIOEAB SEARLE Z5MG;Z5MGSPIRNIOLACTOHE-HYDROCHLOROTHIAZID EAB MYLAN PHARMS ZSNG;Z5HGSPIRONOLACTCHE WI HYDROCHLOROTHIAZIDEAB BOLAR PHARM ZSt1G; Z5MGAB CORD LABS ZSMG;ZSNGAB ZENITH LABS ZSMG;ZENGHYDROCHLOROTHIAZIDE; TRIAHTERENECAPSULE; ORALDYAZIDESK&F25MG;50MGHYDROCODONE BITARTRATE; *MULTIPLE*SEE ACETAMINOPHEN; HYDROCODONE BITARTRATEHYDROCORTISONEAEROSOL; TOPICALAEROSEB-HCHERBERT LAB/ALLERGAN a.5?CREAM; RECTALPROCTOCORTROWELL LABSCREAM; TOPICALCORT-DOMEAT DOME LABS/MILES LABS a.s? M 1?DERMACORTAT ROWELL LABS 1?ELDECORTAT PAUL B ELDER a.s? M 1? M Z.S?,It-CORTAT PHARM ASSOCIATES O.S? M 1?- HC (HYDROCORUSOHE) -- -AT C AND M PHARMACAL 0.=1. M 1?HC #lAT DOME LABS/MILES LABS O.S?1%HYDROCORTISONECREAM; TOPICALHC #4AT DOME LABS/MILES LABS 1?H:I-CORAT C AND M PHARMACAL Z.S?'HYDROCORUSOHEAT AMBIX LABS/ORGANICS O.S? M 1? M Z.S?'AT BIOCRAFT LABS a.s? M 1? M Z.S?,AT BYK-GULDEN a.s? M 1?AT CLAY-PARK LABS a.s? M 1? M Z.S?'AT G AND W LABS 1?AT INGRAM PHARM O.S? M 1?AT LEMMON PHARMACAL 1?AT SHAFFER-DAVIS LABS O.S? M 1?AT STAN LABS PHARM O.S? M 1?AT STIEFEL LABS 1?AT SYOSSET LABS O.S? M 17-AT TOWNE PAULSEN O.S? M 1?HYTOHEAT DERMIK LABS/RORER a.s? M 1? M Z.S2HUTRACORTAT OWEN LABS/ALCON LABS O.S? M 1?ENEMA; RECTALCORTEHEMAAT ROWELL LABS 1aOMG/60MLRECTOIDAT PHARMACIA LABS 100MG/60MLATATATGEL; TOPICALNUTRACORTOWEN LABS/ALCON LABS 1%INJECTABLE; INJECTIONCORTEFUPJOHN50MG/MLLOTION; TOPICALCETACORTOWEN LABS/ALCON LABS a.s? M 12CORT-DOMEDOME LABS/MILES LABS 0.52 M 1?DELACORTMERICON INDUSTRIES O.S?
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST67ATATATATATATATATATATATATATATHYDROCORTISONELOTION; TOPICALDE~MACO~TROWELL LABS O.S? M 1?EP:ICORTBLUE LINE LABS O.S? M 1?H-CORTPHARM ASSOCIATES O.S?HYD~OCORT:rSOHECLAY-PARK LABS O.S? M 1?TOWNE PAULSEN O.S?HUT~ACORTOWEN LABS/ALCON LABS O.S? M 1?TEXACO~TPARKE-DAVIS/W-L 1?OINTMENT; TOPICALCORT~:rLPFIPHARMECS/PFIZERHC (HYDROCORT:ISOHE)C AND M PHARMACALHYD~OCORT:rSOHEA~lBIX LABS/ORGANICSBYK-GULDENCLAY-PARK LABSSHAFFER-DAVIS LABSHYTOHEDERMIK LABS/RORER1? M 2.S?'O.S? M 1?O.S? M 1? M 2.S?'0.57. M 17.O.S? M 17. M 2.57.0.57. M 17.0.57. M 17. M 2.57.POWDER; FOR RX COMPOUNDINGHYDROCORTISONEPHARMA-TEK10GM/BOT * 50GM/BOTSOLUTION/DROPS; OPHTHALMICOPTEFUPJOHN 0.2?TABLET; ORALCORTEFBP UPJOHN IOMG * 20MG5MGCORTRILBP PFIZER LABS 10MG * 20NGHYCORTOLEBP PREMO PHARM LABS 20MGHYDROCORTISONETABLET; ORALHYDROCORTISONEBP ANABOLICBP BARR LABSBP DANBURY PHARMACALBP INWOOD LABS/FORESTBP KETCHUM LABSBP LANNETTBP MK LABSBP PANRAY/ORNONT DRUGBP PUREPAC PHARMBP RICHLYN LABSBP STAN LABS PHARMBP TOWNE PAULSENBP WEST-WARDHYDROCORTONEBP MERCK SHARP & DOHMETABLET; VAGINALCORTRILPFIPHARMECS/PFIZERHYDROCORTISONE ACETATEAEROSOL; TOPICALEP:IFOAMAT REED & CARNRICKHYDROCORT:ISOHEAT BLOCK DRUG20MG20MG20MG20MG20MG20MGIOMG * 20MG10MG * 20MG20MG20MGIOMG * 20MGIOMG * 20MG20MGIOMG * 20MGIOMGCREAM; TOPICALHYDROCORTISOHE ACETATEAT PUREPAC PHARM O.S?M 17.AT TOWNE PAULSEN O.S? M 1?TUCKS HCAT FULLER LABS1?INJECTABLE; INJECTIONCORTEF ACETATEBP UPJOHN50MG/MLCORTRILBP PFIZER LABS25MG/MLHYDROCORTISONE ACETATEBP BEL-MAR LABS25MG/ML * 50NG/ML17.1?
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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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PERCORTEN PIVALATE, DESOXYCORTICOST
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oAPPROVED PRESCRIPTION DRUG PRODUCT
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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