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

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PRESCRIPTION DRUG PRODUCTS DEEMED APPROVEDPENDING RESOLUTION OF SAFETY OR EFFECTIVENESS ISSUES6CURRENT STATUS - "EXEMPT" (COURT ORDER)NYSTATIN NEOMYCIN GRAMICIDIN TRIAMCINOLONE EFOUGERA/BYK-GUGRAMICIDIN; NEOMYCIN SULFATE; NYSTATIN;TRIAI'ICINOLONE ACETONIDEOMNI-TUSS PENNWALTCHLORPHENIRAMINE; CODEINE; EPHEDRINE; GUAIACOL CARBONATE;PHENYLTOLOXAMINEOPHTflOCORT PARKE-DAVISIW-LCHLORAMPHENICOL; HYDROCORTISONE ACETATE; POLYMYXIN B SULFATEORUADE SKF LABSCHLORPHENIRAMINE MALEATE; ISOPROPAMIDE IODIDE;PHENYLPROPANOLAMINE HYDROCHLORIDEPARNATE SKF LABSTRANYLCYPROMINE SULFATEPATHIBAMATE-200 LEDERLE LABS lAM CYANMEPROBAMATE; TRIDIHEXETHYL CHLORIDEPATHIBAIIATE-400 LEDERLE LABS/AM CYANMEPROBAtIATE; TRIDIHEXETHYL CHLORIDEPATHILON WI PHENOBARBITAL LEDERLE LABS/AM CYANPHENOBARBITAL; TRIDIHEXETHYL CHLORIDEPBZ WI CODEINE AND EPHEDRINE ,GEIGYPHARMSAl"!t10NIU!1 CHLORIDE; CODEINE SULFATE; EPHEDRINE SULFATE;TRIPELENNAMINE CITRATEPBZ WI EPHEDRINE GEIGY PHARtlSANnoNIUtl CHLORIDE; EPliEDRINE SULFATE; TRIPELENNANINE CITRATEEPHEDRINE SULFATE; TRIPELENNAMINE HYDROCHLORIDEPBZ-SR GEIGY PHARMSTRIPELENNANINE HYDROCHLORIDEPENT-T 80 MERICON INDUSTRIESPENTAERYTHRITOL TETRANITRATEPEHTAERYTHRITOL TETRANITATE DANBURY PHARMACALPENTAERYTHRITOL TETRANITRATEPENTAERYTHRITOL TETRA-NITRATE BOLAR PHARMPENTAERYTHRITOL TETRANITRATEPENTAERYTHRITOL TETRAtUTRATE CORD LABSPENTAERYTHRITOL TETRANITRATEPENTAERYTHRITOL TETRANITRATE KIRKMAN LABSPENTAERYTHRITOL TETRANITRATEPENTAERYTHRITOL TETRANITRATE VITARINEIWEST CHEMPENTAERYTHRITOL TETRANITRATEPENTAERYTHRITOL TETRANITRATE WEST-WARDPENTAERYTflRITOL TETRANITRATEPENTAERYTHRITOL TETRANITRATE ZENITH LABSPENTAERYTHRITOL TETRANITRATEPENTESTAN-80 STAND EX LABSPENTAERYTHRITOL TETRANITRATEPENTRAN NO.1 HALSEY DRUGPENTAERYTHRITOL TETRANITRATECURRENT STATUS.,. "EXEMPT" (COURT ORDER)PENTRAN NO.2 HALSEY DRUGPENTAERYTHRITOL TETRANITRATEPENTRITOL ARMOUR PHARMPENTAERYTHRITOL TETRANITRATEPENTRYATE OJF/CHROMALLOYPENTAERYTHRITOL TETRANITRATEPERITRATE PARKE-DAVIS/W-LPENTAERYTHRITOL TETRANITRATEPERITRATE SA PARKE-DAVISIW-LPENTAERYTHRITOL TETRANITRATEPERSANTINE BOEHRINGER INGELHEIMDIPYRIDAtIOLEPHENERGAN EXPECTORANT WYETH LABS/AMHOCITRIC ACID; IPECAC; POTASSIUM GUAIACOLSULFONATE;PRotIETHA.ZINE HYDROCH LOR ID EIPECAC; POTASSIUM GUAIACOLSULFONATE;PROMETHAZINE HYDROCHLORIDE; SODIUM CITRATEPHENERGAN EXPECTORANT 14/ CODEINE WYETH LABS/AHHOCODEINE PHOSPHATE; IPECAC FLUIDEXTRACT;POTASSIUM GUAIACOLSULFONATE; PROMETHAZINE HYDROCHLORIDECODEINE PHOSPHATE; IPECAC; POTASSIUM GUAIACOLSULFONATE;PROMETHAZINE HYDROCHLORIDEPHENERGAN EXPECTORANT 14/ DEXTROMETHORPHAN WYETH LABS/AHHODEXTROI'IETHORPHAN HYDROBRONIDE; IPECAC FLUIDEXTRACT;POTASSIUN GUAIACOLSULFONATE; PROtlETHAZINE HYDROCHLORIDEPHENERGAN VC EXPECTORANT WYETH LABS/AMHOIPECAC FLUIDEXTRACT; PHENYLEPHRINE HYDROCHLORIDE;POTASSIUM GUAIACOLSULFONATE; PRotlETHAZINE HYDROCHLORIDEPHENERGAN VC EXPECTORANT 14/ CODEINE WYETH LABS/ANHOCODEINE PHOSPHATE; IPECAC FLUIDEXTRACT;PHENYLEPHRINE HYDROCHLORIDE; POTASSIUM GUAIACOLSULFONATE;PROtlETHAZINE HYDROCHLORIDEPREDtIYCIN-P ALLERGAN PHARI1SNEOMYCIN SULFATE; POLYNYXIN B SULFATE; PREDNISOLONE ACETATEPRO-BANTHINE WI PHENOBARBITAL SEARLEPHENOBARBITAL; PROPANTHELINE BRONIDEPROTERtlOL KEY PHARMSISOPROTERENOL HYDROCHLORIDEPROTERNOL-HS KEY PHt.RHSISOPROTERENOL HYDROCHLORIDEROBINUL-PH AH ROBINSGLYCOPYRROLATE; PHENOBARBITALROBINUL-PH FORTE AH ROBINSGLYCOPYRROLATE; PHENOBARBITALSORBITRATE ICI AtlERICASISOSORBIDE DINITRATESORBITRATE STUART PHARHS/ICIISOSORBIDE DINITRATE
PRESCRIPTION DRUG PRODUCTS DEEMED APPROVEDPENDING RESOLUTION OF SAFETY OR EFFECTIVENESS ISSUES7CtmREHT STATUS - "EXEMPT" (COtmT ORDER)SORBITRATE STUART PHARMS/ICIISOSORBIDE DINITRATESULFATHALIDINE MERCK SHARP & DOHMEPHTHALYLSULFATHIAZOLESUSTAC FOREST LABSNITROGLYCERINSUSTACHRON FOREST LABSNITROGLYCERINT.C.M. 200 ZENITH LABSMEPROBAMATE; TRIDIHEXETHYL CHLORIDET.C.M. 400 ZENITH LABSMEPROBAMATE; TRIDIHEXETHYL CHLORIDETERRA-CORTRIL PFIZER LABSHYDROCORTISONE ACETATE; OXYTETRACYCLINE HYDROCHLORIDEHYDROCORTISONE; OXYTETRACYCLINE HYDROCHLORIDEHYDROCORTISONE; OXYTETRACYCLINE HYDROCHLORIDE;POLYMYXIN B SULFATETETRASULE-80 ARt-lAR-STot-lE LABSPENTAERYTHRITOL TETRANITRATETETRATE-80 PASADENA RESEARCHPENTAERYTHRITOL TETRANITRATETHEOPHEDRINE W/ PHENOBARBITAL SMITH MILLER PATCHEPHEDRINE HYDROCHLORIDE; PHENOBARBITAL; THEOPHYlLINETHEPHORHI 14/ CODEINE AND PAPAVERINE HOFHIANN-LA ROCHEAMtl0NIUM CHLORIDE; CHLOROFORM; CODEINE PHOSPHATE;PAPAVERINE HYDROCHLORIDE; PHENINDAMINE TARTRATETUSS-ORNADE SKF LABSCARAMIPHEN EDISYlATE; CHLORPHENIRAtlINE MALEATE;ISOPROPAMIDE IODIDE; PHENYLPROPANOLAMINE HYDROCHLORIDETJSSIONEXPEN~~ALTHYDROCODONE; PHENYLTOLOXAMINEULOMINIC RIKER LABS/3MCHLOPHEDIANOL HYDROCHLORIDE; DIPHENYlPYRALINE HYDROCHLORIDE;GUAIFENESIN; PHENYlEPHRINE HYDROCHLORIDEVI-SYNERAL FISONSASCORBIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN;THIAMINE; TOCOPHEROLS; VITAMIN A; VITAMIN 0WINSTEROID WINTHROP P/STERLINGSTAI'-:OZOLOLWINSTROL WINTHROP l/STERLINGSTANOZOLOLCURRENT STATUS - EFFECTIVENESS TO BE DETERMINEDCLYSODRAST BARNES-HIND PHARMSBISACOOYlLEVO-DROMORAN HOFFMAHN-LA ROCHELEVORPHANOL TARTRATECURRENT STATUS - EFFECTIVENESS TO BE DETERMINEDLEVO-DROMORAN HOFFMANN-LA ROCHELEVORPHANOL TARTRATENISENTIL HOFFMANN-LA ROCHEALPHAPRODINE HYDROCHLORIDESYNKAMIN PARKE-DAVIS/W-LVITAMIN K5CURRENT STATUS - EFFECTIVE/NEW SAFETY ISSUEAMIGEN MEAD JOHNSON/BMPROTEIN HYDROLYSATEHYGROTON USV LABSCH LORTHA LIDONEKAON~IARREN-TEED/ADRIAPOTASSIUM GLUCONATEPITOCIN CITRATE PARKE-DAVIS/W-LOXYTOCIN CITRATEPOTASSIUM CHLORIDE ELI LILLYPOTASSIUM CHLORIDE·U.S. GOVERNMENT PRINTING OFFICE: <strong>1980</strong> 0-328-651/6548
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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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"~''''''-- .APPROVED PRESCRIPTION D
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PERCORTEN PIVALATE, DESOXYCORTICOST
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oAPPROVED PRESCRIPTION DRUG PRODUCT
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