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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST116PSEUDOEPHEDRINE HYDROCHLORIDECAPSULE, CONTROLLED RELEASE; ORALNOVAFEDBC DOW PHARMS l20MGSUDAFEDBC BURROUGHS WELLCOME l20MGPSEUDOEPHEDRINE SULFATE; *MULTIPLE*SEE DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATEPYRANTEL PAMOATESUSPENSION; ORALANTIMINTHROERIG/PFIZEREQ 250MG BASE/SMLAPAPAPAPAPAPAPAPPYRIDOXINE HYDROCHLORIDEINJECTABLE; INJECTIONHEXA-BETALIHELI LILLYPYRIDOXIHE HCLBEL-MAR LABSCARTER-GLOGAU LABSD-M PHARMACEUTICALSDELL LABSINVENEX PHARMS/MOGULNATCON CHEMICALVITARINE/WEST CHEMlOOMG/MLlOOMG/MLlOOMG/MLlOOMG/MLlOOMG/ML50MG/MLlOOMG/MLlOOMG/MLlOOMG/I1LPYRIDOXINE HYDROCHLORIDE; *MULTIPLE*SEE DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDEPYRAZINAMIDETABLET; ORALPYRAZINAMIDELEDERLE LABS/AM CYAN 500MGPYRIDOSTIGMINE BROMIDEINJECTABLE; INJECTIONI1ESTIHOHAP HOFFMANN-LA ROCHEREGOHOLAP ORGANON/AKZONASYRUP; ORALNESTINONHOFFMANN-LA ROCHETABLET; ORALMESTINONHOFFMANN-LA ROCHE5MG/MLSMG/ML60MG/SML60MGTABLET, CONTROLLED RELEASE; ORALMESTINONHOFFMANN-LA ROCHE l80MGPYRILAMINE MALEATETABLET; ORALPYRILAMIHE MALEATEAA BOLAR PHARMAA CHELSEA LABSAA RICHLYN LABSPYRIMETHAMINETABLET; ORALDAR APR INBURROUGHS WELLCOMEPYRVINIUM PAMOATESUSPENSION; ORALPOVANPARKE-DAVIS/W-LTABLET; ORALPOVANPARKE-DAVIS/W-L2511G25MG2511G25NGEQ SONG BASE/SMLEQ SOMG BASE
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST117QUINESTROLQUINIDINE SULFATETABLET; ORALCAPSULE; ORALESTROVISCIH-qUIHPARKE-DAVIS/W-L 100 UGM * 200 UGM AB ROWELL LABS 200MB300MGqUIHIDIHE SULFATEQUINETHAZONEAB ELI LILLY200MBTABLET; ORALHYDROMOXLEDERLE LABS/AM CYAN SOMGQUINETHAZONEi RESERPINETABLET; ORALHYDROHOX RLEDERLE LABS/AM CYAN 50MG;125 UGMQUINIDINE GLUCONATEINJECTABLE; INJECTIONQUINIDINE GLUCONATEELI LILLYTABLET; ORALQUINACTBERLEX LABS/S-AGSOMG/ML266MG * 400MGTABLET, CONTROLLED RELEASE; ORALDURAQUINPARKE-DAVIS/W-L 330MGQUINAGLUTEBERLEX LABS/S-AG 324MGQUINIDINE PDLYGALACTURONATETABLET; ORALCARDIOQUINPURDUE FREDERICK275MGTABLET; ORALCIH-qUIHAB ROWELL LABSqUIHIDIHE SULFATEAB BARR LABS 200MBAB BEECHAM LABS 200MBAB BELL PHARMACAL ~AB CARNEGIE LABS/REXALL 200MGAB CHELSEA LABS ~AB CORD LABS 200MBAB DANBURY PHARMACAL 200MGAB DANIELS PHARMS 200MBAB ELI LILLY 200MBAB FIRST TEXAS PH ARMS ~AB HALSEY DRUG 200MGAB HEUN-NORWOOD LABS 200MGAB ICN PHARMS 200MGAB KETCHUM LABS ~AB LANNETT ~200MB If 300MBlOOMGAB LEDERLE LABS/AM CYAN 200MBAB PARKE-DAVIS/W-L 200MBAB PHARMAVITE PHARMS 200MGAB PHILIPS ROXANE LABS ~ If ~AB PHOENIX LABS ~AB PRIVATE FORMULATIONS 200MBAB PUREPAC PHARM 200MGAB REXALL DRUG 200MBAB RICHLYN LABS 200MBAB STAN LABS PHARH 200MGAB TOWNE PAULSEN 200MGAB VITARINE/WEST CHEM ~AB WEST-WARD !QQtl§AB ZENITH LABS 200MSqUIHO~AAB KEY PH ARMS 200MB If 300MBTABLET, CONTROLLED RELEASE; ORALQUINIOEXAH ROBINS300MG
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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 PRESCRIPTIOH DRUG PRODUCTS
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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