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

More documents

Recommendations

Info

APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST106PIPERAZINE CITRATETABLET; ORALPIPERAZINE CITRATERICHLYN LABSPIPERAZINE ESTRONE SULFATECREAM; VAGINALOGENABBOTT LABSTABLET; ORALOGENABBOTT LABSPIPOBROMANTABLET; ORALVERcYTEABBOTT LABSEQ 250MG BASE1.5MG/GM750 UGN * 1.5MG * 3MG * 6MG10MG * 25MGPOLYMYXIN B SULFATE; *MULTIPLE*SEE BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATESEE CHLORAMPHENICOL; POLYMYXIN B SULFATESEE GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATESEE HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATESEE HYDROCORTISONE; POLYMYXIN B SULFATESEE NEOMYCIN SULFATE; POLYMYXIN B SULFATESEE OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATEPOL YTHIAZIDETABLET; ORALRENESEPFIZER LABSIMG * 2MG * 4MGPOLYTHIAZIDE; PRAZOSIN HYDROCHLORIDECAPSULE; ORALMINIZIDEPFIZER LABS500 UGM;lMG * 500 UGM;2MG * 500 UGM;5MGPOLYESTRADIOL PHOSPHATEPOLYTHIAZIDEi RESERPINEINJECTABLE; INJECTIONESTRADURINAYERST LABS/AMHO40HG/AMPTABLET; ORALRENESE-RPFIZER LABS2MG;250 UGMPOLYMYXIN B SULFATEINJECTABLE; INJECTIONPOLYMIXIN B SULFATEPFIZER LABS500,000 UNITS/VIALPOWDER; FOR RX COMPOUNDINGPOLY-RXPHARMA-TEK100,000,000 UNITS/VIALPOTASSIUM ACETATE; *MULTIPLE*SEE AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE;SODIUM CHLORIDESEE AMINO ACIDS; MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUMACETATE; POTASSIUM CHLORIDE; SODIUM ACETATESEE DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUMACETATE; SODIUM CHLORIDESEE DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUMCHLORIDEPOLYMYXIN B SULFATE; *MULTIPLE*SEE BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATESEE BACITRACIN ZINC; POLYMYXIN B SULFATEPOTASSIUM AMINOSALICYLATECAPSULE; ORALPASKALIUMGLENWOOD LABS500MG
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST107POTASSIUM AMINOSALICYLATEPOWDER; ORALPASKALrUMAA GLENWOOD LABS 3GM/PACKETPOTASS~UMAM~HOSAL~CYLATEAA MARSCHALl/MILES LABS 100?APTABLET; ORALPASKALIUMGLENWOOD LABSPOTASSIUM CHLORIDEINJECTABLE; INJECTIONPOTASS~UMABBOTT LABSCHLOR~DEAP AM MCGAW/AM HOSPAPAP CUTTER LABSAPAPAPELI LILLYELKINS-SINN/AHROBINS~ INT'L MEDICATION SYSAP INVENEX LABSAP INVENEX PHARMS/MOGULAP NATCON CHEMICALAP TORIGIAN LABSAP TRAVENOL LABSAPAP VITARINE/WEST CHEMSOOMG * IGMTABLET, CONTROLLED RELEASE; ORALK-TABBC ABBOTT LABS 7S0MGKAON-CLWARREN-TEED/ADRIAKLOTRIXSOOMGBC MEAD JOHNSON/BM 7S0MGSLOW-KCIBA PHARMlMEg/ML * 2MEQ/MLI.SMEQ/ML * 2.4MEQ/ML * 3.2MEQ/MLlMEg/ML * 2MEg/ML * 3MEg/Ml *4HEg/MllMEQ/Ml * 2MEg/Ml * 3MEQ/Ml *4MEg/Ml2HEg/Ml2MEg/Ml2MEg/MLZMEg/MlZMEg/Ml * !MEg/ML2ME(VMLZMEg/MllMEg/Ml * 2MEg/Ml * !MEg/Ml *4MEg/MlZHEg/HlSMEQ/ML600MGPOTASSIUM CHLORIDE; *MULTIPLE*SEE AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACIDiPOTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDESEE AMINO ACIDS; MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUMACETATE: POTASSIUM CHLORIDE; SODIUM ACETATESEE CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE iPOTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE;SODIUM L.ACTATESEE CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUMCHLORIDESEE CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUMCHLORIDE; SODIUM LACTATESEE CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUMACETATE i SODIUM CHLORIDESEE CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUMCHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATESEE CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDESEE CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE;SODIUM LACTATESEE DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE;POTASSIUM PHOSPHATE. MONOBASIC; SODIUM CHLORIDE; SODIUMLACTATESEE DEXTROSE: MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUMACETATE; SODIUM CHLORIDE; SODIUM GLUCONATESEE DEXTROSE; POTASSIUM CHLORIDESEE DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE - INPLASTICSEE MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE;SODIUM CHLORIDE; SODIUM GLUCONATEPOTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE; INJECTIONSODIUM CHLORIDE 0.9% & POTASSIUM CHLORIDE 0.07S% IN PLASTICCONTAINERTRAVENOL LABS 7SMG/I00ML;900MG/I00MLSODIUM CHLORIDE 0.97, & POTASSIUM CHLORIDE 0.157. IN PLASTICCONTAINERTRAVENOL LABS IS0MG/I00ML;900MG/I00MLSODIUM CHLORIDE 0.97. & POTASSIUM CHLORIDE 0.2247. IN PLASTICCONTAINERTRAVENOL LABS 224MG/I00ML;900MG/I00MLSODIUM CHLORIDE 0.97. AND POTASSIUM CHLORIDE 0.37. IN PLASTICCONTAINERTRAVENOL LABS 300MG/I00ML;900MG/I00ML
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
Page 22 and 23:
and the rate of absorption.pharmace
Page 24 and 25:
4. Erythromycin stearate Tablets -
Page 27 and 28:
II. LISTINGSA. FORMAT GUIDEThis p..
Page 29 and 30:
CURRENT STATUS - POSSIBLY EFFECTIVE
Page 31 and 32:
DRUG ProDUCT EKAMPLESSingle Ingredi
Page 33 and 34:
APPROVED PRESCRIPTION DRUG PRODUCTS
Page 35 and 36:
Page 37 and 38:
Page 39 and 40:
Page 41 and 42:
Page 43 and 44:
Page 45 and 46:
Page 47 and 48:
Page 49 and 50:
Page 51 and 52:
Page 53 and 54:
Page 55 and 56:
j./APPROVED PRESCRIPTION DRUG PRODU
Page 57 and 58:
Page 59 and 60:
Page 61 and 62:
Page 63 and 64:
Page 65 and 66:
-,----APPROVED PRESCRIPTION DRUG PR
Page 67 and 68:
APPROVED PRESCRI~TIOHDRUG PRODUCTSD
Page 69 and 70:
Page 71 and 72:
Page 73 and 74:
Page 75 and 76:
Page 77 and 78:
DIMENHYDlHNATEAPPROVED PRESCRIPTION
Page 79 and 80:
Page 81 and 82:
------"".,APPROVED PRESCRIPTION DRU
Page 83 and 84:
Page 85 and 86:
Page 87 and 88: APPROVED PRESCRIPTION DRUG PRODUCTS
Page 91 and 92: APPROVED ¥RESCRIPTION DRUG PRODUCT
Page 95 and 96: '''"APPROVED PRESCRIPTION DRUG PROD
Page 97 and 98: ----..//APPROVED PRESCRIPTION DRUG
Page 125 and 126: "~''''''-- .APPROVED PRESCRIPTION D
Page 137: APPROVED PRESCRIPTION DRUG PRODUCTS
Page 189 and 190:
PERCORTEN PIVALATE, DESOXYCORTICOST
Page 191 and 192:
Page 193 and 194:
Page 195:
oAPPROVED PRESCRIPTION DRUG PRODUCT
Page 198 and 199:
Page 200 and 201:
Page 202 and 203:
Page 204 and 205:
Page 206 and 207:
Page 208 and 209:
Page 210 and 211:
Page 212 and 213:
Page 214 and 215:
Page 216 and 217:
Page 218 and 219:
Page 220 and 221:
Page 222 and 223:
Page 224 and 225:
APPROVED PRESCRIPTIOH DRUG PRODUCTS
Page 226 and 227:
Page 228 and 229:
Page 230 and 231:
Page 232 and 233:
Page 234 and 235:
Page 237 and 238:
Page 239 and 240:
Page 241 and 242:
Page 243:
Page 246 and 247:
PRESCRIPTION DRUG PRODUCTS DEEMED A
Page 248 and 249:
Page 250 and 251:
show all

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

Create successful ePaper yourself

Delete template?

Save as template?