first edition (1980) of the Orange Book - FDA Law Blog
first edition (1980) of the Orange Book - FDA Law Blog first edition (1980) of the Orange Book - FDA Law Blog
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST2ACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET; ORALOXYCODONE 2.S/APAP SOOENDO LABS/DUPONT 500MGi2.SMGOXYCODONE S/APAP 500ENOO INCSOOMGiSMGPERCOCET-SAA ENDO LABS/DUPONT 32SMG;SMGACETAMINOPHEN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATECAPSULE; ORALTYLOXMCNEIL LABSSOOMG;4.SMG;380 UGMACETAMINOPHEN; PHENACETIN; PHENYLPROPANOLAMINE HYDROCHLORIDE;PHENYLTOLOXAHINE CITRATETABLET, CONTROLLED RELEASE; ORALSINUBIDPARKE-DAVIS/W-L 300MGi300MG;100MG;66MGACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDETABLET; ORALDOlEHE AP-65AALEDERLE LABS/AM CYAN 6S0MG;6SMGPROPOXYPHEHE HCl WI APAPAA MYLAN PH ARMS 6S0MG;6SMG32SMG;32MGWYGESJ:CAA WYETH LABS/AMHO 650MG;6SMGACETAMINOPHEN; PROPOXYPHENE NAPSYLATETABLET; ORALDARVOCET-N 100ELI LILLYDARVOCET-N SOELI LILLY650MG;100MG32SMG;SOMGACETAZOLAMIDECAPSULE, CONTROLLED RELEASE; ORALDIAMOX. LEDERLE LABS/AM CYAN SOOMGTABLET; ORALACETA20lAMJ:DEAB BOLAR PHARM 2S0MGAB LANNETT 2S0MGDJ:AMOXAB LEDERLE LABS/AM CYAN ~12SMGATATATAIATACETAZOLAMIDE SODIUMINJECTABLE; INJECTIONDIAMOXLEDERLE LABS/AM CYAN SOOMG/VIALACETIC ACID, GLACIALSOLUTION; IRRIGATIONACETIC ACID 0.257. IN PLASTIC CONTAINERABBOTT LABS2S0MG/100MLSOLUTION; IRRIGATION, URETHRALACETJ:C ACJ:D O.2S? J:H PlASTJ:C COHTAJ:HERABBOTT LABS2S0MG/100MlAM MCGAW/AM HOSP 2S0MG/100MLSOLUTION; OTICORLEXBAYLOR LABS !ZHEUN-NORWOOD LABS 2?VOSOlWALLACE LABS/C-W 2?ACETIC ACID, GLACIAL; ALUMINUM ACETATESOLUTION; OTICDOMEBORODOME LABS/MILES LABS 27.;0.797.
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST3ACETIC ACID, GLACIAL; DESONIDESOLUTION; OTICTRIDESIlONDOME LABS/MILES LABS 2y'jSOO UGM/MLACETYLCHOLINE CHLORIDESOLUTION/DROPS; OPHTHALMICMIOCHOLSMITH MILLER PATCH 20MG/VIAlACETIC ACID, GLACIAL; HYDROCORTISONESOLUTION; OTICACETIC ACID WI HYDROCORTISOHEAT HEUN-NORWOOD LABS 2Z;lZORLEX HCAT BAYLOR LABS ~;lZveSOL HCAT WALLACE LABS/C-W ZZ;lZACETYLCYSTEINESOLUTION; INHALATIONMUCOMYSTMEAD JOHNSON/BM lOY. * 20Y.ACETYLCYSTEINEi ISOPROTERENOL HYDROCHLORIDESOLUTION; INHALATIONMUCOMYST W/ ISOPROTERENOLACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATE MEAD JOHNSON/BM 10Y.;0.OSY.SUSPENSION; OTICNEO-CORT-DOMEDOME LABS/MILES LABS 2X;1Y.;EQ 0.3SZ BASEACETOHEXAMIDETABLET; ORALDYMELORELI LILLYACETOPHENAZINE MALEATETABLET; ORALTINDALSCHERINGACETRIZOATE SODIUMINJECTABLE; INJECTIONSALPIXORTHO PHARM2S0MG * SOOMG20MG530MG/I1LACETYLDIGITOXINTABLET; ORALACYLANIDSANDOZ PHARMSACRISORCINCREAM; TOPICALAKRIHOLSCHERING100 UGM2MG/GMALBUMIN, CHROMATED, CR-Sl, SERUMINJECTABLE; INJECTIONCHROMALBINER SQUIBB AND SONS 100 UCI/VIAL * 2S0 UCI/VIAL *500 UCI/VIALALBUMIN, IODINATED, 1-125, SERUMINJECTABLE; INJECTIONALBUMOTOPE 125 IER SQUIBB AND SONS5-50 UCI/AMP
- Page 5: RXD AND DRUG ACMINISTRATIONAPProVED
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- Page 14 and 15: To assist the user in relating the
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- Page 20 and 21: B - Drug products that FDA does not
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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST3ACETIC ACID, GLACIAL; DESONIDESOLUTION; OTICTRIDESIlONDOME LABS/MILES LABS 2y'jSOO UGM/MLACETYLCHOLINE CHLORIDESOLUTION/DROPS; OPHTHALMICMIOCHOLSMITH MILLER PATCH 20MG/VIAlACETIC ACID, GLACIAL; HYDROCORTISONESOLUTION; OTICACETIC ACID WI HYDROCORTISOHEAT HEUN-NORWOOD LABS 2Z;lZORLEX HCAT BAYLOR LABS ~;lZveSOL HCAT WALLACE LABS/C-W ZZ;lZACETYLCYSTEINESOLUTION; INHALATIONMUCOMYSTMEAD JOHNSON/BM lOY. * 20Y.ACETYLCYSTEINEi ISOPROTERENOL HYDROCHLORIDESOLUTION; INHALATIONMUCOMYST W/ ISOPROTERENOLACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATE MEAD JOHNSON/BM 10Y.;0.OSY.SUSPENSION; OTICNEO-CORT-DOMEDOME LABS/MILES LABS 2X;1Y.;EQ 0.3SZ BASEACETOHEXAMIDETABLET; ORALDYMELORELI LILLYACETOPHENAZINE MALEATETABLET; ORALTINDALSCHERINGACETRIZOATE SODIUMINJECTABLE; INJECTIONSALPIXORTHO PHARM2S0MG * SOOMG20MG530MG/I1LACETYLDIGITOXINTABLET; ORALACYLANIDSANDOZ PHARMSACRISORCINCREAM; TOPICALAKRIHOLSCHERING100 UGM2MG/GMALBUMIN, CHROMATED, CR-Sl, SERUMINJECTABLE; INJECTIONCHROMALBINER SQUIBB AND SONS 100 UCI/VIAL * 2S0 UCI/VIAL *500 UCI/VIALALBUMIN, IODINATED, 1-125, SERUMINJECTABLE; INJECTIONALBUMOTOPE 125 IER SQUIBB AND SONS5-50 UCI/AMP
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