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

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AEROSOLCAPSULECAPSULE, CONTROLLED RELEASECONCENTRATECREAMDRESSINGDROPSELI XIREMULSIONENEMAFILM, CONTROLLED RELEASEGASGELGRANULEINJECTABLEINSERT, CONTROLLED RELEASEINTRAUTERINE DEVICEJELLYLIQUIDLOTIONTABLE IDOSAGE FORMSOINTMENTPASTEPELLETPOWDERPOWDER FOR RECONSTITUTIONSHAMPOOSOAPSOLUTIONSPONGESPRAYSUPPOSITORYSUSPENSIONSWABSYRUPTABLETTABLET, CHEWABLETABLET, CONTROLLED RELEASETABLET, EFFERVESCENTTABLET, ENTERIC COATEDTAMPONTAPEBUCCALIMPLANTATIONINHALATIONINJECTIONINTRATRACHEALINTRAUTERINEIRRIGATIONNASALOPHTHALMICTABLE I IROUTES OF ADMINISTRATIONORALOTICPERCUTANEOUSRECTALSUBLINGUALTOPICALURETERALURETHRALVAGINALTABLE I IIABBREVIATIONSAMPAMPULEMEQMI LLI EQUI VALENTAMPICIL AMPICILLIN MG MI LLIGRAMBOT BOTTLE ML MI LLI LITERCI CURl E N/ A NOT APPLICABLEEQ EQUIVALENT TO SQ CM SQUARE CENTIMETERFL OZ FLUID OUNCE UCI MICROCURIEGM GRAM UGM MICROGRAMHCL HYDROCHLORIDE UL MICROLITERL LITER UMOLAR MICROMOLARMCI MILLICURIEII - 4
DRUG ProDUCT EKAMPLESSingle IngredientActive Ingredient.. MEPERIDINE HYDROCHLORIDEDosage Form; Route <strong>of</strong> Administratioo• INJECTABLE; INJECTIONDEHEROL. N AP WINTHROP VSTER LING 2SMG/ML '" SOHG/ML '" 7SMG/ML '"T ra de or G ener IC ames AP lOOMG/MLL...-________ ....: HEPERIDZHE HCLTherapeutic 19quivalence (TE)Af ELKINS-SINN/AHROBINS 2SMGIML '" SOHG/ML '" 7SMG/ML '"100MG/M1,Code for Multisource Prodoct• AP. INT'L MEDICATION SYS lOMGIMLAP KNOLL PHARM2SMG/ML '" 50MS/ML '" 7SMG/ML '"Af100HG/MLAP PARKE-DAVIS/W-L SOMG/ML '" 7SMG/ML '" 100MG/HLSingle Source Product (NO TE Code) ___ AP VITARINE/wEST CHEM SOMG/ML '" 100MG/ML~AP WYETH LABS/ANtiO 2SMG/ML '" SOMG/ML '" 7SMG/ML '"AP100MG/MLL..-_______ ~. DEMEROLSYRUP; ORALAWlicatioo Holder • WINTHROP VSTERLING 50MG/5MLAsterisks Separate Available Strengths <strong>of</strong> a Product--------------------------------------~AlphabeticallyFirst Active IngredientMultiple Ingredientswi th Product Informatioo--------------------------------~.~ EPIHEPHRIN~ LIDOCAINE HYDROCHLORIDEProdlct Informatioo • ~1MINJECTABLE; INJECTIONALPHACAZHE HeL W/ EPZHEPHRIHECARLISLE LABS 10 UGM/ML;2? * 20 UGMIML;2?With Cross-ReferenceAlphabeticallySecond Active Ingredient • LIDOCAINE HYDROCHLQRIDE; *I1ULTIPLE*SEE DEXAMETHASONE SODIUM PHOSPHATE; LIDOCAINE HYDROCHLORIDECross-Reference toSEE DEXTROSE; LIDOCAINE HYDROCHLORIDEProduct Informatim• SEE EPINEPHRINE i LIDOCAINE HYDROCHLORIDE
Page 5: RXD AND DRUG ACMINISTRATIONAPProVED
Page 9: approved application, a list of app
Page 12 and 13: products that have been approved" i
Page 14 and 15: To assist the user in relating the
Page 16 and 17: an evaluatien of therapeutic equiva
Page 18 and 19: ioavailability data is required for
Page 20 and 21: B - Drug products that FDA does not
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Page 24 and 25: 4. Erythromycin stearate Tablets -
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Page 29: CURRENT STATUS - POSSIBLY EFFECTIVE
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APPROVED PRESCRIPTION DRUG PRODUCTS
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oAPPROVED PRESCRIPTION DRUG PRODUCT
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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