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

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APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX6BEL-MAR LABSTESTOSTERONE PROPIONATE, TESTOSTERONE PROPIONATETHIAMINE HCL, THIAMINE HYDROCHLORIDEVITAMIN A PALMITATE, VITAMIN A PALMITATEBELL FHARMIICALCHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATEDIPHENHYDRAMINE HCL, DIPHENHYDRAMINE HYDROCHLORIDEISONIAZID, ISONIAZIDMEPROBAI'IATE, MEPROBAMATEPREDNISOLONE, PREDNISOLONEPREDNISONE, PREDNISONEPROPYLTHIOURACIL, PROPYLTHIOURACILQUINIDINE SULFATE, QUINIDINE SULFATERESERPINE, RESERPINESODIUM PENTOBARBITAL, PENTOBARBITAL SODIUMSODIUM SECOBARBITAL, SECOBARBITAL SODIUMTHEOPHYLLINE, THEOPHYLLINEBERLEX LABS/S-AGELIXOPHYLLIN, THEOPHYLLINEPYOCIDIN, HYDROCORTISONEQUINACT, QUINIDINE GLUCONATEQUINAGLUTE, QUINIDINE GLUCONATESUS-PHRINE, EPINEPHRINEVI-TWEL, CYANOCOBALAMINB!OCRAFT LABSAMITRIPTYLINE HCL, AMITRIPTYLINE HYDROCHLORIDEAMOXICILLIN, AMOXICILLIN TRIHYDRATEAMPICILLIN, AMPICILLIN/AMPICILLIN TRIHYDRATECLOXACILLIN SODIUM, CLOXACILLIN SODIUM MONOHYDRATEHYDROCORTISONE, HYDROCORTISONEIMIPRAMINE HCL, IMIPRAMINE HYDROCHLORIDENEOMYCIN SULFATE, NEOMYCIN SULFATEOXACILLIN SODIUM, OXACILLIN SODIUM MONOHYDRATEPENICILLIN G POTASSIUM, PENICILLIN G POTASSIUMPENICILLIN V POTASSIUM, PENICILLIN V POTASSIUMPENICILLIN VK, PENICILLIN V POTASSIUMBLOCK DFWGHYDROCORTISONE, HYDROCORTISONE ACETATEBLIJEL!NE LABSEPICORT, HYDROCORTISONEMULTIFUGE, PIPERAZINE CITRATE!Ht;ELHF.I:MALUPEtlT, METAPROTERENOL SULFATECATAPRES, CLONIDINE HYDROCHLORIDECOMBIPRES, CHLORTHALIDONEPRELUDIN, PHENMETRAZINE HYDROCHLORIDEBO"HR!HGE~BOLAR FHAr.?MACETAZOLAMIDE, ACETAZOLAMIDEANISOTROPINE METHYLBROMIDE, ANISOTROPINE METHYLBROMIDEBETHANECHOL CHLORIDE, BETHANECHOL CHLORIDEBROMPHENIRAMINE MALEATE, BROHPHENIRAMINE MALEATECARISOPRODOL, CARISOPRODOLCARISOPRODOL COMPOUND, CAFFEINECH LORtlEZANONE, CH LORMEZANONECHLOROTHIAZIDE, CHLOROTHIAZIDECHLOROTHIAZIDE WI RESERPINE, CHLOROTHIAZIDECHLORPHENIRI\MINE MALEATE, CHLORPHENIRAMINE ~IALEATECYPROHEPTADINE HCL, CYPROHEPTADINE HYDROCHLORIDEDEXAMETHASONE, DEXAMETHASONEDIPHENHYDRAMINE HCL, DIPHENHYDRAMINE HYDROCHLORIDEFOLIC ACID, FOLIC ACIDGLYCOPYRROLATE, GLYCOPYRROLATEHYDRALAZINE HCL, HYDRALAZINE HYDROCHLORIDEHYDROCH LOROTH IAZIDE, HYDROCH LOROTHIAZID EHYDROCHLOROTHIAZIDE WI HYDRALAZINE, HYDRALAZINE HYDROCHLORIDEHYDROCHLOROTHIAZIDE WI RESERPINE, HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE WI RESERPINE AND HYDRALAZINE, HYDRALAZINEHYDROCHLORIDEHYDROGENATED ERGOT ALKALOIDS, DIHYDROERGOCORNINE MESYLATEIMIPRAllINE HCL, IMIPRAMINE HYDROCHLORIDEISONIAZID, ISONIAZIDMECLIZINE HCL, MECLIZINE HYDROCHLORIDEMEPROBAMATE, MEPROBAMATEMETHOCARBAMOL, METHOCARBAMOLNIACIN, NIACINNITROFURANTOIN, NITROFURANTOINPRIMIDONE, PRIMIDONEPROBENECID WI COLCHICINE, COLCHICINEPROCAINAMIDE HCL, PROCAINAMIDE HYDROCHLORIDEPROCHLORPERAZINE, PROCHLORPERAZINE MALEATEPROI'IETHAZINE HCL, PROMETHAZINE HYDROCHLORIDEPROPANTHELINE BROMIDE, PROPANTHELINE BROMIDEPYRILAMINE MALEATE, PYRILAMINE MALEATERESERPINE, RESERPINESPIRONOLACTONE, SPIRONOLACTONESPIRONOLACTONE WI HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDESULFAMETHOXAZOLE, SULFAMETHOXAZOLESULFASALAZINE, SULFASALAZINETRIAMCINOLONE, TRIAMCINOLONETRICHLORNETHIAZIDE, TRICHLORMETHIAZIDETRICHLORI1ETHIAZIDE WI RESERPINE, RESERPINETRIHEXYPHENIDYL HCL, TRIHEXYPHENIDYL HYDROCHLORIDE
APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX7BOLAR PHARMTRIPELENNAMINE HCL, TRIPELENNAMINE HYDROCHLORIDETRIPROLIDINE HCL, TRIPROLIDINE HYDROCHLORIDEBOOTS PHA!
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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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Page 151 and 152: APPROVED PRESCRIPTION DRUG PRODUCTS
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Page 246 and 247: PRESCRIPTION DRUG PRODUCTS DEEMED A
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