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

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APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX32SERONO LABS :INCASELLACRIN, SOMATOTROPINSHAFFER-DAVIS LABSHYDROCORTISONE, HYDROCORTISONENITROFURAZONE, NITROFURAZONETRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDESK&FDIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDEDYAZIDE, KYDROCHLOROTHIAZIDEDYRENIUM, TRIAMTERENESTELAZINE, TRIFLUOPERAZINE HYDROCHLORIDESK&F LAB COTAGAMET, CIMETIDINETAGAMET, CIMETIDINE HYDROCHLORIDESKF L~,BSANCEF, CEFAZOLIN SODIUMANSPOR, CEPHRADINEBENZEDRINE, AMPHETAMINE SULFATECONPAZINE, PROCHLORPERAZINECOMPAZINE, PROCHLORPERAZINE EDISYLATECOMPAZINE, PROCHLORPERAZINE MALEATECYTOMEL, LIOTHYRONINE SODIUMDARBID, ISOFROPAMIDE IODIDEDEXEDRINE, DEXTROAMPHETAtlINE SULFATEESKALITH, LITHIUM CARBONATEPAREDRINE" HYDROXYAMPHETAMINE HYDROBROMIDESK-BAMATE, MEPROBAMATESK-DIFHENHYDRA!1INE, DIPHENHYDRAMINE HYDROCHLORIDESK-HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDESK-LYGEN, CHLORDIAZEPOXIDE HYDROCHLORIDESK-PRAMINE, IMIPRAMINE HYDROCHLORIDESK-SOXAZOLE, SULFISOXAZOLESK-TOLBUTAMIDE, TOLBUTAMIDESK-65, PROPOXYPHENE HYDROCHLORIDESK-65 cmlPOUND, ASPIRINSTOXIL, IDOXURIDWETAGANET, CIMETIDINE HYDROCHLORIDETEMARIL, TRII1EPRAZINE TARTRATETHORAZINE, CHLORPROMAZINE HYDROCHLORIDEURISPAS, FLAVOXATE HYDROCHLORIDEVONTROL, DIPHENIDOL HYDROCHLORIDESMJ:TH MILLER PATCHCATARASE, CHYMOTRYPSINFUNDUSCEIN-25, FLUORESCEIN SODIUMINFLAMASE, PREDNISOLONE SODIUM PHOSPHATEINFLAMASE FORTE, PREDNISOLONE SODIUM PHOSPHATEMIOCHOL, ACETYLCHOLINE CHLORIDESULF-lO, SULFACETAMIDE SODIUMVASOCON, NAPHAZOLINE HYDROCHLORIDESPERT:I DRUG PRODSPREDNISOLONE, PREDNISOLONEPREDNISONE, PREDNISONESgurBB/J:TALYPENICILLIN G SODIUM, PENICILLIN G SODIUMSTAKLABS FH,d~MAMINOPHYLLINE, AMINOPHYLLINEAPAP W/ CODEINE PHOSPHATE, ACETAMINOPHENCH LOROQUn~E PHOSPHATE, CH LOROQUINE PHOSPHATECORTISONE ACETATE, CORTISONE ACETATEDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATEFOLIC ACID, FOLIC ACIDHYDROCORTISONE, HYDROCORTISONEMEPROBAtlATE, MEPROBAMATEMETHYLTESTOSTERONE, METHYLTESTOSTERONENIACIN, NIACINPREDNISOLONE, PREDNISOLONEPREDNISONE, PREDNISONEQUINIDINE SULFATE, QUINIDINE SULFATERESERPINE, RESERPINESECOBARBITAL SODIUM, SECOBARBITAL SODIUMSODIUM PENTOBARBITAL, PENTOBARBITAL SODIUMSTANOZIDE, ISONIAZIDSTANSIN, SULFISOXAZOLESULFADIAZINE, SULFADIAZINETRIPLE SULFA, TRISULFAPYRIMIDINESVITAtlIN A, VITAMIN AVITAMIN A, VITAMIN A PALMITATEVITAMIN 0, ERGOCALCIFEROLSTERI-MED/KETCtfl.1MDIPHENHYDRAMINE HCL, DIPHENHYDRAMINE HYDROCHLORIDEPREDNISONE, PREDNISONESULFACEL-15, SULFACETAMIDE SODIUMVITAMIN A, VITAMIN A PALMITATE
APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX33SEROHO LABS :rHeASEllACRIN, SOMATROPINSTJ:EFEL LA\,!S .ESCABIOl, lINDANEHYDROCORTISONE, HYDROCORTISONESTUART PHA"Ns/rc:rBUClADIN-S, BUClIZINE HYDROCHLORIDESURV:rVAL TECHHOLOGYATROPEN, ATROPINElIDOPEN, lIDOCAINE HYDROCHLORIDESYHTEX LABSANADROl-50, OXYMETHOlONECARMOl HC, HYDROCORTISONE ACETATEEVEX, ESTROGENS, ESTERIFIEDlIDEX, FlUOCINONIDElIDEX-E, FlUOCINONIDESYNAlAR, FlUOCINOlONE ACETONIDESYNALAR-HP, F LUOCINOlONE ACETONIDESYNEMOl, FlUOCINOlONE ACETONIDETOPSYN, FlUOCINONIDESYHTEX P RNAPROSYN, NAPROXENSYHTEX(F P)BREVICON 2h ETHINYl ESTRADIOLBREVICON 28, ETHINYL ESTRADIOLNOR-Q.D., NORETHINDRONENORINYl, MESTRANOLNORINYL 1+50 21, MESTRANOLNORINYl 1+50 28, MESTRANOLNORINYl 1+80 21, MESTRANOLNORINYl 1+80 28, MESTRANOLSYO!iSET LABSFlUTEX, TRIA~lCINOlONE ACETONIDEHYDROCORTISONE, HYDROCORTISONESELENIUM SULFIDE, SELENIUM SULFIDE** T **TABL!CAPSAMINOPHYllINE, AMINOPHYLLINEBRor1PHENIRAMINE MALEATE, BROMPHENIRAMINE MALEATECHlORPHENIRAMINE MALEATE, CHlORPHENIRAMINE MALEATEFOLIC ACID, FOLIC ACIDMEPROBAMATE, MEPROBAMATEMETHOCARBAMOl, METHOCARBAMOL** T **TABLJ:CAPSMETHYLTESTOSTERONE, METHYLTESTOSTERONENIACIN, NIACINPREDNISOLONE, PREDNISOLONEPREDNISONE, PREDNISONEPROMETHAZINE HCl, PROMETHAZINE HYDROCHLORIDEPROPANTHELINE BROMIDE, PROPANTHElINE BROMIDEPROPYLTHIOURACIL, PROPYLTHIOURACILRAUWOLFIA SERPENTINA, RAUWOLFIA SERPENTINARESERPINE, RESERPINESTILBESTROL, DIETHYLSTILBESTROLTRIHEXYPHENIDYl HCl, TRIHEXYPHENIDYl HYDROCHLORIDETRIPELENNAMINE HCl, TRIPELENNAMINE HYDROCHLORIDETOR!GrA"f LABSHEPARIN SODIUM, HEPARIN SODIUMPOTASSIUM CHLORIDE, POTASSIUM CHLORIDEPAULSEHACETAMINOPHEN 14/ CODEINE PHOSPHATE, ACETAMINOPHENBUTABARBITAl SODIUM, BUTABARBITAL SODIUMCHlORPHENIRAMINE MALEATE, CHlORPHENIRAMINE MALEATECORTISONE ACETATE, CORTISONE ACETATEDEXAMETHASONE, DEXAMETHASONEDIPHE~mYDRAMINE HCl, DIPHENHYDRAMINE HYDROCHLORIDEFOLIC ACID, FOLIC ACIDH.R.-50, HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDEHYDROCORTISONE, HYDROCORTISONEHYDROCORTISONE ACETATE, HYDROCORTISONE ACETATEISONIAZID, ISONIAZIDMEPROBAMATE, MEPROBAMATEMETHYLTESTOSTERONE, METHYLTESTOSTERONENITROFURANTOIN, IUTROFURANTOUIPENTOBARBITAL SODIUM, PENTOBARBITAL SODIUMPREDNISOLONE, PREDNISOLONEPREDNISONE, PREDNISONEPROMETHAZINE HCl, PROMETHAZINE HYDROCHLORIDEPROPOXYPHENE COMPOUND 65, ASPIRINPROPOXYPHENE HCl, PROPOXYPHENE HYDROCHLORIDEQUINIDINE SULFATE, QUINIDINE SULFATERESERPINE, RESERPINESECOBARBITAL SODIUM, SECOBARBITAL SODIUMSOlVISYN A, VITAMIN A PALMITATETETRACYCLINE HCL, TETRACYCLINE HYDROCHLORIDETO~JflE
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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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-,----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
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Page 177 and 178: APPROVED PRESCRIPTION DRUG PRODUCTS
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