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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST130TESTOSTERONE CYPIONATEINJECTABLE; INJECTIONDEPO-TESTOSTEROHEAO UPJOHN lOOMG/Ml If 200MG/MlSONG/NLTESTOSTERONE CYPIONATEAOADCARTER-GLOGAU LABSD-M·PHARMACEUTICALSlOOMG/MllOOMG/Ml If ZOOMG/MlTESTOSTERONE CYPIONATEi *MULTIPLE*SEE ESTRADIOL CYPIONATEi TESTOSTERONE CYPIONATETESTOSTERONE ENANTHATEINJECTABLE; INJECTIONDELATESTRYlAO ER SQUIBB AND SONS 200MG/MlTESTOSTERONE EHANTHATEAO D-M PHARMACEUTICALS 200MG/MLlOONG/MLTESTOSTERONE ENANTHATE; *MULTIPLE*SEE ESTRADIOL VALERATE; TESTOSTERONE ENANTHATETESTOSTERONE PROPIONATEINJECTABLE; INJECTIONTESTOSTERONE PROPIOHATEAO BEL-MAR LABS 2SMG/Ml If SOMG/Ml If lOOMG/MlAO CARTER-GLOGAU LABS ZSHG/Hl If SOMG/Ml If lOOMG/MlAD D-M PHARNACEUTICALS 2SMG/Ml If SOMG/Ml If lOOMG/MlAD ELI LILLY SOMG/MlTETRACYCLINESYRUP; ORALACHROMYCIN VAB LEDERLE LABS/AM CYAN Eg l2SMG HCl/SHlBIOCYClINEAB NATL PHARM MFG/BARRE Eg l2SHG HCl/SMlTETRACYCLINESYRUP; ORALPAHMYCIHAB UPJOHNROBITETAB AH ROBINSSUMYCIHAB ER SQUIBB AND SONSTETRACYClIHEAB MK LABS·AB WEST-WARDTETRACYClIHE HClAB PUREPAC PHARMTETRACYHAB PFIPHARMECS/PFIZERTETRAMEDAB ZENITH LABSTETRACYCLINE HYDROCHLORIDEEq l2SMG HCl/SMlE!,! l2SMG HCl/SMlE!,! 12SMG HCl/SMlE!,! 12SMG HCl/SMlE!,! 12SMG HCl/SHlEg 12SMG HCl/SMlE!,! 12SMG HCl/SMlEQ l2SMG HCl/SMlCAPSULE; ORALACHROMYCIH VAB LEDERLE LABS/AM CYAN 2S0MG If SOOMGBRISTACYClIHEAB BRISTOL LABS/BM 2S0MG If SOOMGCYCLOPARAB PARKE-DAVIS/W-L 2S0MG If SOOMGPAHMYCIHAB UPJOHN2S0MGRETEIAB REID-PROVIDENT LABS 2S0MG If SOOMGROBITETAB AH ROBINS2S0MG If SOOMGSUMYCIHAB ER SQUIBB AND SONS lOOMG If 12SNG If 2S0MG If SOOMGHTRACHElAB RACHELLE LABS2S0MG If SOOMGTETRACYCLIHE HClAB BARR LABS ~ If SOOMGAB CHELSEA LABS2S0MG If SOOMGAB FEDERAL PHARMACAL ~AB GENERIC PHARN/IVY 2S0HG If SOOHGAB HALSEY DRUG2S0HG If SOOHGAB HEATHER DRUG2S0NG If SOOHG
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST131ASASABASABASABABABASABABASTETRACYCLINE HYDROCHLORIDECAPSULE; ORALTETRACYCL:IHE HCLICN PHARHSKETCHUM LABSMK LABSMM MASTMYLAN PHARMSPHILIPS ROXANE LABSPUREPAC PHARMRICHLYN LABSTOWNE PAULSENWEST-WARDWYETH LABS/AMHOZENITH LABSTETRACYHPFIPHARMECS/PFIZER250MG If 500MG250MG125MG If 250MG250MG250MG If 500MG500MG250MG If 500MG100MG If 250MG If 500MG250MG250MG If 500MG250MG If 500MG250HG If SOOMG250MG If 500MGINJECTABLE; INJECTIONACHROMYC:IHAP LEDERLE LABS/AM CYAN 100MG/V:IAL If 2S0HG/V:IAL If SOOMG/V:IALTETRACYHAP PFIZER LABS 100HG/V:IAL If 2S0MG/V:IAL If 500MG/V:IALOINTMENT; OPHTHALMIC, OTICACHROMYCINLEDERLE LABS/AM CYAN 10MG/GMPOWDER FOR RECONSTITUTION; TOPICALTOPICYCLINEPROCTER AND GAMBLE 2.2HG/MLSUSPENSION/DROPS; OPHTHALMICACHROMYCINLEDERLE LABS/AM CYAN I?TABLET; ORALPAHMYC:IHAB UPJOHN 2S0MG If 500MGSUMYC:IHAB ER SQUIBB AND SONS 250MG If SOOMGSOMG * IOOtfGTETRACYCL:IHE HCLAB MYLAN PHARMS 250MG If 500MGTETRACYCLINE PHOSPHATE COMPLEXCAPSULE; ORALTETREXBRISTOL LABS/BM EQ 100MG HCL * EQ 250MG HCL *EQ 500MG HCLTETRAHYDROZOLINE HYDROCHLORIDESOLUTION; NASALTYZINEKEY PHARHSSPRAY; NASALTYZINEKEY PH ARMSTHALLOUS CHLORIDE, TL-201O.OS? * O.l?O.l?INJECTABLE; INJECTIONTHALLOUS CHLOR:IDE TL 201AP MALLINCKRODT IMCJ:/MLAP NEW ENGLAND NUCLEAR IMC:I/MLTHEOPHYlLINECAPSULE; ORALBRONKODYlBP BREON LABS/STERLING 100MG * 200MGTHEOPHYlLINEBP KV PHARMACEUTICAL 100MG * 200MGELIXIR; ORALEL:IXOPHYLL:IHAA BERLEX LABS/S-AG 80HG/15MLLAHOPHYLL:IHAA LANNETT !!.OMG/15MLTHEOL:IX:IRAA PANRAY/ORMONT DRUG !!.OMG/l5MLTHEOPHYLL:IHEAA BAY LABS 80MG/l5MLAA BELL PHARMACAL 80MG/lSMLAA HALSEY DRUG 80MG/lSML
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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 PROD
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----..//APPROVED PRESCRIPTION DRUG
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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