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

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PRESCRIPTION DRUG PRODUCTS DEEMED APPROVEDPENDING RESOLUTION OF SAFETY OR EFFECTIVENESS ISSUES2CURRENT STATUS - INEFFECTIVEMARAX ROERIG/PFIZEREPHEDRINE SULFATE; HYDROXYZINE HYDROCHLORIDE; THEOPHYLLINEMIGRAL BURROUGHS WELLCOMECAFFEINE; CYCLIZINE HYDROCHLORIDE; ERGOTAMINE TARTRATEMILTRATE WALLACE PHARMS/C-W~IEPROBAMATE; PENTAERYTHRITOL TETRANITRATEMIL TRATE 20 WALLACE PHARtlS/C-WMEPROBAMATE; PENTAERYTHRITOL TETRANITRATEMYSTECLIN-F ER SQUIBB AND SONSAtlPHOTERICIN B; TETRACYCLINEMYSTECLIN-V ER SQUIBB AND SONSAMPHOTERICIN B; TETRACYCLINENUTRACORT OWEN LABS/ALCON LABSHYDROCORTISONEONYCHO-PHYTEX UNIMEDBOROTANNIC COMPLEX; SALICYLIC ACIDORENZYf1E MERRELL-NATIONALCHYMOTRYPSIN; TRYPSINORTHOXINE UPJOHNMETHOXYPHENAMINE HYDROCHLORIDEOTOBIOTIC SCHERINGNEOMYCIN SULFATE; SODIUM PROPIONATEOTOCORT LEtltl0N PHARMACALHYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATEOXAINE-M WYETH LABS/AtlHOALUMINUM HYDROXIDE GEL; MAGNESIUM HYDROXIDE; OXETHAZAINEOXSORALEN PAUL B ELDERMETHOXSALENPAPASE PARKE-DAVISIW-LPAPAINPATHILON LEDERLE LABS/AM CYANTRIDIHEXETHYL CHLORIDEPATHILON WI PHENOBARBITAL SEQUELS LEDERLE LABS/AN CYANPHENOBARBITAL; TRIDIHEXETHYL CHLORIDEPERITRATE WI PHENOBARBITAL PARKE-DAVIS/W-LPENTAERYTHRITOL TETRANITRATE; PHENOBARBITALPOT ABA GLENWOOD LABSPOTASSIUM P-AMINOBENZOATEPRISCO LINE CIBA PHARMTOLAZOLINE HYDROCHLORIDEPRO-BANTHINE ~I/ DARTAL SEARLEPROPANTHELINE BROMIDE; THIOPROPAZATE HYDROCHLORIDEPROPION WYETH LABS/AtIHOCALCIUM PROPIONATE; SODIUM PROPIONATERONIACOL HOFFMANN-LA ROCHENICOTINYL ALCOHOL TARTRATERONIACOL TARTRATE HOFFMANN-LA ROCHENICOTINYL ALCOHOL TARTRATECURRENT STATUS - INEFFECTIVERONIACOL TARTRATE, HOFFMANN,..LA ROCHENICOTINYL ALCOHOL TARTRATETERRASTATIN PFIZER LABSNYSTATIN; OXYTETRACYCLINE HYDROCHLORIDETETRASTATIN PFIZER LABSNYSTATIN; TETRACYCLINE HYDROCHLORIDETEXACORT PARKE-DAVISIW-LHYDROCORTISONETIGAN BEECHAM LABSTRIMETHOBENZAMIDE HYDROCHLORIDETRAL GRADUHET ABBOTT LABSHEXOCYCLIUM METHYLSULFATETROCINATE WILLIAM P POYTHRESSTHIPHENAMILUROBIOTIC PFIZER LABSOXYTETRACYCLINE HYDROCHLORIDE;PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHIZOLEVASODILAN MEAD JOHNSON/BMISOXSUPRINE HYDROCHLORIDEWYANOIDS HC WYETH LABS/AHHOBELLADONNA EXTRACT; EPHEDRINE SULFATE; HYDROCORTISONE ACETATEZACTANE WYETH LABS/AHHOETHOHEPTAZINE CITRATEZACTIRIN WYETH LABS/AMHOASPIRIN; ETHOHEPTAZINE CITRATEZACTIRIN CO~IPOUND-IOO WYETH LABS/AMHOASPIRIN; CAFFEINE; ETHOHEPTAZINE CITRATE; PHENACETINCURRENT STATUS - INEFFECTIVE AS COMBINATIONSINEW SAFETY ISSUEESKATROL SKF LABSDEXTROAMPHETAMINE SULFATE; PROCHLORPERAZINE MALEATENATURETIN WI K ER SQUIBB AND SONSBENDROFLUHETHIAZIDE; POTASSIUM CHLORIDERAUTRAX ER SQUIBB AND SONSFLUMETHIAZIDE; POTASSIUM CHLORIDE; RAUUOLFIA SERPENTINARAUTRAX IMPROVED 25 ER SQUIBB AND SONSHYDROFLUMETHIAZIDE; POTASSIUM CHLORIDE; RAUWOLFIA SERPENTINARAUTRAX-N ER SQUIBB AND SONSBENDROFLUMETHIAZIDE; POTASSIUM CHLORIDE; RAUWOLFIA SERPENTINARAUTRAX-N MODIFIED ER SQUIBB AND SONSBENDROFLUMETHIAZIDE'; POTASSIUM CHLORIDE; RAUWOLFIA SERPENTINACURRENT STATUS - "EXEMPT" (COURT ORDER)ACHROMYCIN LEDERLE LABS/AM CYANHYDROCORTISONE; TETRACYCLINE HYDROCHLORIDE
-_.'PRESCRIPTION DRUG PRODUCTS DEEMED APPROVEDPENDING RESOLUTION OF SAFETY OR EFFECTIVENESS ISSUES3CURRENT STATUS - "EXEMPT" (COURT ORDER)ACTIFED BURROUGHS WELLCOMEPSEUDOEPHEDRINE HYDROCHLORIDE, D-; TRIPROLIDINE HYDROCHLORIDEACTIFED-C EXPECTORANT BURROUGHS WELLCOMECODEINE PHOSPHATE; GUAIFENESIN;PSEUDOEPHEDRINE HYDROCHLORIDE, D-; TRIPROLIDINE HYDROCHLORIDEADROYD PARKE-DAVIS/W-LOXYMETHOLONEAMBENYL EXPECTORANT MARION LABSAtlMONIUM CHLORIDE; BROMODIPHENHYDRAMINE HYDROCHLORIDE;CODEINE SULFATE; DIPHE~~YDRAMINE HYDROCHLORIDE; MENTHOL;POTASSIUM GUAIACOLSULFONATEAMODRINE SEARLE PHARMSAMINOPHYLLINE; PHENOBARBITAL; RACEPHEDRINE HYDROCHLORIDEBENADRYL W/ EPHEDRINE SULFATE PARKE-DAVIS/W-LDIPHENHYDRAMINE HYDROCHLORIDE; EPHEDRINE SULFATEBENTYL MERRELL-NATIONALDICYCLOtlINE HYDROCHLORIDEBENTYL W PHENOBARBITAL MERRELL-NATIONALDICYCLOMINEHYDROCHLORIDE; PHENOBARBITALBEROCCA C HOFFMANN-LA ROCHEASCORBIC ACID; DEXPANTHENOL; NIACINAMIDE;PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDEBEROCCA C 500 HOFFtlANN-LA ROCHEASCORBIC ACID; BIOTIN; DEXPANTHENOL; NIACINAMIDE;PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDEBETOLAKE MERRELL-NATIONALo EXPANTH ENO L; NIACINAtlID E; PYR IDOXINE HYDROCH LOR ID E;RIBOFLAVIN; THIAMINE HYDROCHLORIDEBLEPHAMIDE ALLERGAN PHARMSPHENYLEPHRINE HYDROCHLORIDE; PREDNISOLONE ACETATE;SULFACETAMIDE SODIUMCALDECORT PENNWALTCA LCIUI1 UNO ECY LENA TE; HYDROCORTISONE ACETATECANTIL W/ PHENOBARBITAL tlERRELL-NATIONALMEPENZOLATE BROMIDE; PHENOBARBITALCARDIlATE BURROUGHS WELLCOMEERYTHRITYL TETRANITRATECHLORotlYCETIN HYDROCORTISONE PARKE-DAVIS/W-LCH LORAtlPHENICOL; HYDROCORTISONE ACETATECLISTIN EXPECTORANT MCNEIL LABSAtll10NIUM CHLORIDE; CARBINOXAMINE I1ALEATE;POTASSIUM GUAIACOLSULFON.o.TE; SODIUM CITRATECLISTIN RA MCNEIL LABSCARBINOXAMINE MALEATECODITRATE CENTRAL PHARMACALCITRIC ACID; DIHYDROCODEINE BITARTRATE;POTASSIUM GUAIACOLSULFONATEj SODIUM CITRATECURRENT STATUS - "EXEMPT" (COURT ORDER)COR-OTICIN MAURRY BIOLOGICALHYDROCORTISONE ACETATEj NEOMYCIN SULFATECOR-TAR-QUIN DOME LABS/MILES LABSCOAL TAR SOLUTION; DIIODOHYDROXYQUIN; HYDROCORTISONECORDRAN-N ELI LILLYFlURANDRENOLIDE; NEOMYCIN SULFATECORODYL FORTE BOCK PHARMPENTAERYTHRITOL TETRANITRATECORTISPORIN BURROUGHS WELLCOMEBACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE;POLYMYXIN B SULFATEHYDROCORTISONE; NEOMYCIN SULFATE; POLYtlYXIN B SULFATECORTISPORIN G BURROUGHS WELLCOMEGRAMICIDIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE;POLYMYXIN B SULFATEDACTIL MERRELL-NATIONALPIPERIDOLATE HYDROCHLORIDEDACTIL AND PHENOBARBITAL MERRELL-NATIONALPHENOBARBITAL; PIPERIDOLATE HYDROCHLORIDEDAR ICON PB PFIZER LABSOXYPHENCYCLIMINE HYDROCHLORIDE; PHENOBARBITALDECA-DURABOLIN ORGANON/AKZONANANDROLONE DECANOATEDIAHABOL CIBA PHARMMETHANDROSTENOLONEDICYCLOMINE NATL PHARM ~FG/BARREDICYCLONINE HYDROCHLORIDEDICYCLOMINE HCL BARR LABSDICYCLONINE HYDROCHLORIDEDICYCLONINE HCL BOLAR PHARMDICYCLOMINE HYDROCHLORIDEDICYCLOMINE HCL CHELSEA LABSDICYCLONINE HYDROCHLORIDEDICYCLOtlINE HCL DANBURY PHARMACALDICYCLOMINE HYDROCHLORIDEDICYCLONINE HCL GENERIC PHARM/IVYDICYCLONINE HYDROCHLORIDEDICYCLOMINE HCLLANI~ETTDICYCLOIlINE HYDROCHLORIDEDICYCLOMINE HCL LEDERLE LABS/AM CYANDICYCLCNINE HYDROCHLORIDEDICYCLOIlINE HCL LEMNON PHARMACALDICYCLOHINE HYDROCHLORIDEDICYCLot1!NE HCL PRIVATE FORMULATIONSDICYCLOHINE HYDROCHLORIDEDICYCLOMINE HCL TABLICAPSDICYCLOHINE HYDROCHLORIDE
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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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PERCORTEN PIVALATE, DESOXYCORTICOST
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