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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST128TANNIC ACID; *MULTIPLE*SEE CYANOCOBALAMIN; TANNIC ACIDi ZINC ACETATETECHNETIUM, TC-99M GENERATORISODIUM PERTECHNETATE, TC-99MSOLUTION; INJECTION, ORALCINTICHEM TECHNETIUM 99M GENERATORUNION CARBIDE RADIO 830-16,600MCI/GENERATORMINITECER SQUIBB AND SONS 220-2, 220MCI/GENERATORTECHNETIUM TC 99M GENERATORNEW ENGLAND NUCLEAR 225-2,700MCI/GENERATORULTRA-TECHNEKOW FMMALLINCKRODT O.25-3CI/GENERATORTECHNETIUM. TC-99M. ALBUMIN AGGREGATEDINJECTABLE; INJECTIONTC 99M-LUNGAGGREGATEMEDI-PHYSICS5MCI/MLTECHNETIUM. TC-99M, ALBUMIN AGGREGATED KITINJECTABLE; INJECTIONA-N STANNOUS AGGREGATED ALBUMINBS A-N RADIOPHARMS N/AAGGREGATED ALBUMIN (HUMAN) KITBS CIS RADIOPHARMS N/AALBUMIN MICROSPHERES (HUMAN) INSTANT MICROSPHERESBS DIAGNOSTIC PRODS/3M N/ACINTICHEM TECHNETIUM 99M MAABS UNION CARBIDE N/ALUNGAGGREGATE REAGENTBS MEDI-PHYSICS N/AMACROTECBS ER SQUIBB AND SONS N/APULMOLITEBS NEW ENGLAND NUCLEAR N/ATECHNESCAN MAABS MALLINCKRODT N/ATECHNETIUM, TC-99M, ALBUMIN KITINJECTABLE; INJECTIONCINTICHEM TECHNETIUM 99M HSAUNION CARBIDE N/A'TECfI'HETIUM. TC-99M. ETIDRONATE KITINJECTABLE; INJECTIONCIHTICHEM TECHHETIUM 99M HEDSPAAP UNION CARBIDE H/AMPI STAHNOUS DIPHOSPHOHATEAP MEDI-PHYSICS N/AOSTEOSCAHAP PROCTER AND GAMBLE H/ATECHNETIUM TC 99M DIPHOSPHOHATE-TIH KITAP DIAGNOSTIC ISOTOPES H/ATECHNETIUM. TC-99M. GLUCEPTATE KIT.INJECTABLE; INJECTIONGLUCOSCANNEW ENGLAND NUCLEARN/ATECHNETIUM. TC-99M. MEDRONATE KITINJECTABLE; INJECTIONAH-MDPAP ACKERMAN NUCLEAR KIAMDP Kl:TAP DIAGNOSTIC ISOTOPES H/AOSTEOL:ITEAP NEW ENGLAND NUCLEAR H/ATECHNESCAK MDP KITAP MERCK SHARP & DOHME KIATECHNETIUM, TC-99M. PENTETATE KITINJECTABLE; INJECTIONCINTICHEM TECHHETIUM 99M DTPA:
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST129TECHNETIUM, TC-99M, PENTETATE KITTECHNETIUM, TC-99M, SULFUR COLLOID KITINJECTABLE; INJECTIONKXDHEV/BRAXH SCAHHIHG KXTAI' GENERAL RADIOISOTOPE H/ARENOTECBS ER SQUIBB AND SONS N/ATECHHETXUM TC 99M DTPA (5H) KXTAi' CIS RADIOPHARtlS H/ATECHNETIUM, TC-99M, POLYPHOSPHATE KITAPAPAPAPINJECTABLE; INJECTIONCXHTXCHEM TECHHETXUM 99M TSCUNION CARBIDE H/ASULFUR COLLOXD KZTCIS RADIOPHARMS H/ATECHHECOLLMALllNCKRODTH/ATESULOIDER SQUIBB AND SONS H/AINJECTABLE; INJECTIONSODIUM POLYPHOSPHATE-TIN KITDIAGNOSTIC ISOTOPES N/ATECHNETIUM, TC-99M, PYRO/TRIHETA PHOSPHATES KITINJECTABLE; INJECTIONPYROllTENEW ENGLAND NUCLEARN/ATECHNETIUM, TC-99M, PYROPHOSPHATE KITINJECTABLE; INJECTIONBOHE SCAHHXHG KITAP GENERAL RADIOISOTOPE H/APHOSFHOTECAP ER SQUIBB AND SONS H/ATECHHESCAH PVP KITAP MALLINCKRODT H/ATECHNETIUM, TC-99M, SULFUR COLLOIDINJECTABLE; INJECTIONTECHNETIUM TC 99M SULFUR COLLOIDCIS RADIOPHARMS 2MCI/HLGAMMA DIAG LABS 3MCI/MLMEDI-PHYSICS4MCI/MLTERBUTALINE SULFATEINJECTABLE; INJECTIONBRICANYlASTRA PHARM PRODSTABLET; ORALBRETHINEBP GEIGY PHARMSBRICANYlBP ASTRA PHARH PRODSTESTOLACTONE.INJECTABLE; INJECTIONTESLACER SQUIBB AND SONSTABLET; ORALTEStACER SQUIBB AND SONSTESTOSTERONEPELLET; IMPLANTATIONORETONBP SCHERINGTESTOSTERONEBP BARTOR PHARMACALIMG/ML2.5MG if 5MG2.5MG if 5MGlOOMG/ML50MG * 250MG75MG75MG
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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 PRESCRIPTION DRUG
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APPROVED PRESCRIPTIOH DRUG PRODUCTS
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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