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

More documents

Recommendations

Info

APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST120SECOBARBITAL SODIUMAAAAAAAAAAAAAAAAAAAAAAAAAACAPSULE; ORALSECOBARBITAL SODIUMPARKE-DAVIS/W-LPUREPAC PHARMSTAN LABS PHARMTOWNE PAULSENVITARINE/WEST CHEMZENITH LABSSODIUM SECOBARBITALANABOLICBARR LABSBELL PHARMACALCHELSEA LABSHALSEY DRUGHEUN-NORWOOD LABSWEST-WARDlOOMG~lOOMGlOOMGlOOMGlOOMG100MG100MG100MGlOOMG100MG100MG100MGINJECTABLE; INJECTIONSECOBARBITAL SODIUMELKINS-SINN/AHROBINS 100MG/VIALSECONAL SODIUMELI LILLY250MG/AMPSODIUM SECOBARBITALWYETH LABS/AMHO 50MG/MLSELENIUM SULFIDELOTION/SHAMPOO; TOPICALEXSELAT HERBERT LAB/ALLERGAN 2.5?IOSEL 250AT OWEN LABS/ALCON LABS 2.5?SELENIUM SULFIDEAT NATL PHARM MFG/BARRE 2.5?AT SYOSSET LABS 2.S?'~AT ABBOTT LABS 2.5?SELENOMETHIONINE, SE-75INJECTABLE; INJECTIONSELENOMETHIONIHE SE 75AP AMERSHAM/RADIOCHEM 100 UCI/MLSELENOMETHIONINE, SE-75INJECTABLE; INJECTIONSELENOMETHIONIHE SE 75AP CIS RADIOPHARMS 250 UCIIMLAP DIAGNOSTIC ISOTOPES 250 UCI/MLAP MALLINCKRODT 100 UCI/MLSETHOTOPEER SQUIBB AND SONS 85-550 UCIIMLSERACTIDE ACETATEINJECTABLE; INJECTIONACTHAR GEL-SYNTHETICARMOUR PHARMSILVER SULFADIAZINECREAM; TOPICALSI LVAD ENEMARION LABSSINCALIDEINJECTABLE; INJECTIONKINEVACER SQUIBB AND SONSSITOSTEROLSUSPENSION; ORALCYTELLINELI LILLY40 UNITS/ML * 80 UNITS/MLIX5 UGMIVIAL3GM/15MLSODIUM ACETATE; *MULTIPLE*SEE AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID;POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDESEE AMINO ACIDS; MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUMACETATE; POTASSIUM CHLORIDE; SODIUM ACETATESEE AMINO ACIDS; MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUMPHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST121SODIUM ACETATE; *HULTIPLE*SEE AMINO ACIDS; MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUMPHOSPHATE. DIBASIC; SODIUM ACETATE; SODIUM CHLORIDESEE CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE;POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE;SODIUM LACTATESEE CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUMACETATE; SODIUM CHLORIDESEE CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUMCHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATESEE DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUMACETATE; SODIUM CHLORIDE; SODIUM GLUCONATESEE MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE;SODIUM CHLORIDE; SODIUM GLUCONATESODIUM AMINOSALICYLATEPOWDER; ORALP.A.S. SOnI:UMAA CENTURY PHARMS 4GM/PACKETSODI:UM AMI:HOSALICYLATEAA MARSCHALL/MILES LABS lOO?TABLET; ORALPAIMSAL SODI:UMAD PANRA Y /ORtl0NT DRUG SOOMGIGMSODIUM P.A.S.LANNETTTEEBACIN690MGBP CONSOLIDATED MIDLAND 500MGSODIUM AMINOSALICYLATE; *MULTIPLE*SEE AMINOSALICYLIC ACID; SODIUM AMINOSALICYLATEAPAPAPAPSODIUM CHLORIDEINJECTABLE; INJECTIONSODIUM CHLORI:DEABBOTT LABSAM MCGAW/AM HOSPCUTTER LABSSODIUM CHLOR.I:DE INAM MCGAW/AM HOSP20GM/lOOML20GM/IOOML20GM/IOOMLPLASTI:C CONTAINER900MG/lOOMLSODIUM CHLORIDEINJECTABLE; INJECTIONSODIUM CHLORI:DE O.4S? IN PLASTIC COHTAIHERAP ABBOTT LABS ~SOMG/l.OOMLAP AM MCGAW/AM HOSP 4S0MG/lOOMLSODIUM CHLORIDE O.4S? IN WATER IH PLASTIC CONTAINERAP TRAVENOL LABS 4s0MG/lOOMLSODI:UH CHLORIDE O.9? IN PLASTIC CONTAINERAP ABBOTT LABS 900MG/IOOMLAP TRAVENOL LABS 900MG/lOOMLSOLUTION; IRRIGATIONSODIUM CHLORIDE IN PLASTI:C CONTAIHERAT CUTTER LABS 900MG/lOOHLSODIUM CHLORIDE O.4S? IN PLASTI:C COHTAI:HERAT ABBOTT LABS 4S0MG/IOOMLAT TRAVENOL LABS 4S0MG/lOOMLSODI:UH CHLORI:DE O.9? IH PLASTI:C COHTAINERAT ABBOTT LABS 900MG/IOOMLAT AM MCGAW/AM HOSP 900MG/lOOMLAT TRAVENOL LABS 900~IG/lOOMLSODIUM CHLORIDE - IN PLASTIC; *MULTIPLE*SEE DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE -PLASTICSODIUM CHLORIDE; *MULTIPLE*SEE AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID;POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDESEE AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE;SOD IUI1 CH LOR ID ESEE AMINO ACIDS; MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUMPHOSPHATE. DIBASIC; SODIUM ACETATE; SODIUM CHLORIDESEE AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE.DIBASIC; SODIUM CHLORIDESEE AMMONIUM CHLORIDE; SODIUM CHLORIDESEE CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE;POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE;SODIUM LACTATESEE CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUMCHLORIDE; SODIUM LACTATESEE CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUMCHLORIDEIN
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:
Page 89 and 90:
Page 91 and 92:
APPROVED ¥RESCRIPTION DRUG PRODUCT
Page 93 and 94:
Page 95 and 96:
'''"APPROVED PRESCRIPTION DRUG PROD
Page 97 and 98:
----..//APPROVED PRESCRIPTION DRUG
Page 99 and 100:
Page 101 and 102: APPROVED PRESCRIPTION DRUG PRODUCTS
Page 125 and 126: "~''''''-- .APPROVED PRESCRIPTION D
Page 151: APPROVED PRESCRIPTION DRUG PRODUCTS
Page 189 and 190: PERCORTEN PIVALATE, DESOXYCORTICOST
Page 195: oAPPROVED PRESCRIPTION DRUG PRODUCT
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?