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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST48DYCLONINE HYDROCHLORIDESOLUTION; TOPICALDYCLONEDOW PHARMSDYDROGESTERONE0.57. * 17.TABLET; ORALDUPHASTONBP PHILIPS ROXANE LABS SMG * 10MGGYNORESTBP MEAD JOHNSON/BM SMG * 10MGDYPHYlLINEELIXIR; ORALNEOTHYlLINELENNON PHARMACALINJECTABLE; INJECTIONNEOTHYlLINELEMHON PHARMACAL160MG/1SMLSOOHG/2MLTABLET; ORALDILORBP SAVAGE/BYK-GULDEN 200MGDIlOR-400BP SAVAGE/BYK-GULDEN 400MGLUFYlLINBP WALLACE LABS/C-W 200MG * 400MGNEOTHYlLINEBP LEHMON PHARHACAL 200MG * 400MGEDETATE CALCIUM DISODIUMINJECTABLE; INJECTIONVERSENATERIKER LABS/3MTABLET; ORALVERSENATERIKER LABS/3MEDETATE DISODIUM200MG/MLSOOMGINJECTABLE; INJECTIONDJ:SODJ:UH EDETATEAP D-M PHARMACEUTICALS 150HGIHL[DETATE DJ:SODJ:UHAP CARTER-GLOGAU LABS 150HG/HLEHDRATEAP ABBOTT LABS 150HG/HLSODIUM VERSENATERIKER LABS/3M 200MG/MLEDETATE SODIUM; *HULTIPLE*SEE ALKYL AMMONIUM SULFONIC ACID BETAINE (SULFOBETAINE DEHl;AMMONIUM SALT OF C-12-C-15. LINEAR PRIMARY ALCOHOLETHOXYLATEj EDETATE SODIUM; ETHOMEEN C-2S;HEXACHLOROPHENE; LANOLIN ALCOHOLS. ACETYLATEDEDROPHONIUM CHLORIDEINJECTABLE; INJECTIONTENSIlONHOFFMANN-LA ROCHE10MG/MLECHOTHIOPHATE IODIDEENFlURANESOLUTION/DROPS; OPHTHALMICECHOOJ:DELIQUID; INHALATIONAT ALCON LABS 0.03? M 0.06? M 0.125? M 0.25"/.ETHRANEPHOSPHOLJ:HE J:OOJ:OE OHIO MED PRODS/AIRCO 99.97.AT AYERST LABS/AMHO 0.03? • 0.06? • 0.125? • 0.25?
------"".,APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST49EPINEPHRINEINJECTABLE; INJECTIONSUS-PHRINEBERLEX LABS/S-AG5MG/MLEPINEPHRINE; PROCAINE HYDROCHLORIDEINJECTABLE; INJECTIONPROCAINE HCl W/ EPINEPHRINEBEL-MAR LABS 20 UGM/ML;lX * 20 UGM/MLi2XEPINEPHRINE BITARTRATE; *MULTIPLE*SEE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEEPINEPHRINE; ETIDOCAINE HYDROCHLORIDEINJECTABLE; INJECTIONDURANEST W/ EPINEPHRINEASTRA PHARN PRODS 5 UGN/Mt; o. 5X * 5 UGM/Mt; IX *5 UGM/ML;l.5XEPINEPHRINE; LIDOCAINE HYDROCHLORIDEINJECTABLE; INJECTIONALPHACArHE HCL W/ EPrHEPHRrHEAP CARLISLE LABS 10 UGN/ML;Zl M ZO UGM/ML;ZlLrOOCA:tHE HCL W/ EP:tHEPHRIHEAP ABBOTT LABS 10 UGM/NL;lXAP BEL-MAR LABS 10 UGM/NL;ll M 10 UGM/ML;ZXAP CARTER-GLOGAU LABS 10 UGM/ML;ll M 10 UGM/ML;Z%AP D-M PHARMACEUTICALS 10 UGM/NL;ll M 10 UGM/NL;ZlAP DELL LABS 10 UGM/NL;l% M 10 UGN/NL;ZlAP ELKINS-SINN/AHROBINS 10 UGM/ML;ll M 10 UGM/ML;ZlAP GRAHAM CHEMICAL 10 UGM/NL;Zl M ZO UGN/NL;ZlAP INT'L MEDICATION SYS 10 UGN/ML;llXYLOCArHE W/ EPrHEPHRrHEAP ASTRA PHARN PRODS 10 UGM/ML;ll M 10 UGM/ML;Zl MAPZO UGN/ML;Zl5 UGM/ML;0.5X * 5 UGM/ML;lX *5 UGM/MLil.57. * 5 UGM/ML;2XEPINEPHRINE; PRILOCAINE HYDROCHLORIDEINJECTABLE; INJECTIONCITANEST FORTE,ASTRA PH ARM PRODS ,~i UGM/ML;4XERGOCALCIFEROLCAPSULE; ORALDELTAL:tHAA ELI LILLYDR:tSDOLAA WINTHROP l(STERLINGVITAMIH DAA CHASE CHEMICALAA LANNETTAA PHARMACAPSAAAARICHLYN LABSSTANLABS PHARNAA VITARINE/WEST CHENAA WEST-WARDERGOTAMINE TARTRATEAEROSOL; INHALATIONMEDIHALER ERGOTAMINERIKER LABS/3M50,000 UHITS50,000 UHrTS50,000 UHl:TS50,000 UHITS50,000 UHrTS50,000 UNITS50,000 UHrTS50,000 UHrTS50,000 UHrTS9MG/MLERGOTAMINE TARTRATE; *MULTIPLE*SEE CAFFEINE; ERGOTAMINE TARTRATEERYTHROMYCINOINTMENT; OPHTHALMICILDTYCINDISTA PRODS/LILLYTABLET; ORALERYTHROMYCINABBOTT LABS5MG/GMTABLET"ENTERIC COATED; ORALE-MYCINBX UPJOHN 250MG250MG * 500MG
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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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APPROVED PRESCRIPTION DRUG PRODUCTS
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PERCORTEN PIVALATE, DESOXYCORTICOST
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oAPPROVED PRESCRIPTION DRUG PRODUCT
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APPROVED PRESCRIPTIOH DRUG PRODUCTS
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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