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

More documents

Recommendations

Info

APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX38WYETH LAASn,I"'l,OHYDROXYZINE HCL, HYDROXYZINE HYDROCHLORIDELARGON. PROPIOMAZINE HYDROCHLORIDELIDOCAINE HCL, LIDOCAINE HYDROCHLORIDELO/OVRAL, ETHINYL ESTRADIOLLO/OVRAL-28, ETHINYL ESTRADIOLLO/OVRAL-28 AND FERROUS FUMERATE, ETHINYL ESTRADIOLMEPERGAN, MEPERIDINE HYDROCHLORIDEMEPERIDItre AND ATROPINE SULFATE, ATROPINE SULFATEMEPERIDINE HCL, MEPERIDINE HYDROCHLORIDEOMNIPEN (AMPICILLIN), AtIPICILLIN/AMPICILLIN TRIHYDRATEmINI PEN N, MIPICILLIN SODIUMOVRAL, ETHINYL ESTRADIOLOVRAL-28,. ETHINYL ESTRADIOLOVRAL-28 AND FERROUS FUMARATE, ETHINYL ESTRADIOLOVRETTE, NORGESTRELOXYTOCIN, OXYTOCINPATHOCIL, DICLOXICILLIN SODIUM MONOHYDRATEPEN-VEE K, PENICILLIN V POTASSIUMPENICILLIN G POTASSIUM, PENICILLIN G POTASSIUMPHENERGAl4, PRC!1ETHAZINE HYDROCHLORIDEPHENERGAN FORTIS, pqOMETHAZINE HYDROCHLORIDEPROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATEPROKETAZINE, CARPHENAZINE MALEATEREPOSITORY CORTICOTROPIN, CORTICOTROPINSERAX, OXAZEPAMSODIUM PENTOBARSITAL, PENTOBARBITAL SODIUMSODIUtl SECOBARBITAL, SECOBARBITAL SODIUMSPARINE, PR01'IAZINE HYDROCHLORIDESULFOSE, TRISULFAPYRIMIDINESTETRACYCLINE HCL, TETRACYCLINE HYDROCHLORIDETHIAMINE HCL, TIIIMIINE HYDROCHLORIDETH Iot1ER IN SOD IU:1, MERCAPTot1ER IN SOD IUMumPEN, NI',FCILLIN SODIUt1 r'lO}:OHYDRATE "'WYAMINE SULFATE, MEPHENTERMINE SULFATEWYAMYCIN E, ERYTHROMYCIN ETHYLSUCCINATEWYAMYCIN S, ERYTHRotlYCIN STEARATEWYCILLIN, PENICILLIN G PROCAINEWYDASE, HYALURO~IIDASEWYGESIC, ACETAtHNOPHENWYMOX, AMOXICILLIN TRIHYDRATE** Z **ZEt!:J:Tli LARSACETMIINOPHEN W CODEINE PHOSPHATE #3, ACETAMINOPHENACETANINOPHEN W/ CODEIt4E PHOSPHATE #4, ACETAMINOPHWAMPICI L LIN, AtlPICI L LIN/Af1PICI LLIN TR IHYDRATEAPC W/ BUTALBITAL, ASPIRINBETHANECHOL CHLORIDE, BETHANECHOL CHLORIDEBROMPHENIRAHINE MALEATE, BR011PHEIHRArnNE MALEATECEPHALEXIN MotIOHYDRATE, CEPHALEXIN MONOHYDRATE** Z **ZF.'HITH Lr.SSCHLORAMPHENICOL, CHLORAMPHENICOLCHLORDIAZEPOXIDE HCL, CHLORDIAZEPOXIDE HYDROCHLORIDECHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATECHLORPROMAZINE HCL, CHLORPROtlAZINE HYDROCHLORIDECONJUGATED ESTROGENS, ESTROGENS, CONJUGATEDCORTISONE ACETATE, CORTISOHE ACETATECYPROHEPTADINE HCL, CYPROHEPTADINE HYDROCHLORIDEo EXAtlETHASONE , DEXAMETHASONEDIPHENHYDRAMINE HCL, DIPHENHYDRAMINE HYDROCHLORIDEDIPHENOXYLATE HCL 14/ ATROPINE SULFATE, ATROPINE SULFATEERYTHROMYCIN STEARATE, ERYTHROMYCIN STEARATEFOLIC ACID, FOLIC ACIDGLUTETHItlIDE, GLUTETHIMIDEHYDRALAZINE HCL, HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HCL, HYDROCHLOROTHIAZIDE AND RESERPINE,HYDRALAZINE HYDROCHLORIDEHYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE 14/ RESERPINE, HYDROCHLOROTHIAZIDEISONIAZID, ISONIAZIDMECLIZINE HCL, MECLIZINE HYDROCHLORIDEMEPROBAMATE, MEPROBAMATEMETHOCARBAr10L, METHOCARBAMOLNIACIN, NIACINNITROFURANTOIH, NITROFURANTOINPENICILLIN G POTASSIUM, PENICILLIN G POTASSIUMPENICILLIN V POTASSIUM, PENICILLIN V POTASSIUMPHENDIt1ETRAZIHE TARTRATE, PHENDIMETRAZINE TARTRATEPHENTERMINE HCL, PHENTERMINE HYDROCHLORIDEPHENYTOIN SODIUM, PHENYTOIN SODIUMPREDNISOLONE, PREDNISOLONEPREDNISotlE, PREDNISot;EPROBENECID AtlO COLCHICINE, COLCHICINEPROCAINAMIDE HCL, PROCAINAMIDE HYDROCHLORIDEPROMETHAZINE HCL, PROMETHAZINE HYDROCHLORIDEPROPOXYPHENE COMPOUND 65, ASPIRINPROPOXYPHENE HCL. PROPOXYPHENE HYDROCHLORIDEPROPYLTHIOURACIL, PROPYLTHIOURACILQUINIDINE SULFATE, QUINIDINE SULFATERAU~:OLFIA SERPENTINA, RAUWOL!FIA SERPENTINARESERPINE, RESERPINESECOBARBITAL SODIUtl, SECOBARBITAL SODIUMSODIUM BUTABARBITAL, BUTABARBITAL SODIUtlSODIUM PEtlTOBARBITAL, PENTOBARBITAL SODIUMSPIRONOLACTONE, SPIRONOLACTONESPIRONOLACTONE 14/ HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDESULFISOXA20LE, SULFISOXAZOLETETRACYCLINE HCL, TETRACYCLINE HYDROCHLORIDETETRAMED, TETRACYCLINETOLBUTAMIDE, TOLBUTAMIDE
APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX39** z **ZEt-lJ:TH LABSTRIAMCINOLONE, TRIAMCINOLONETRIPLE SULFA #2, TRISULFAPYRIMIDINESVITAMIN A, VITAMIN A PALMITATE** 3 **3NSCRUBTEAH SURGICAL SPONGEBRUSH, HEXACHLOROPHENE
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:
Page 103 and 104:
Page 105 and 106:
Page 107 and 108:
Page 109 and 110:
Page 111 and 112:
Page 113 and 114:
Page 115 and 116:
Page 117 and 118:
Page 119 and 120:
Page 121 and 122:
Page 123 and 124:
Page 125 and 126:
"~''''''-- .APPROVED PRESCRIPTION D
Page 127 and 128:
Page 129 and 130:
Page 131 and 132:
Page 133 and 134:
Page 135 and 136:
Page 137 and 138:
Page 139 and 140:
Page 141 and 142:
Page 143 and 144:
Page 145 and 146:
Page 147 and 148:
Page 149 and 150:
Page 151 and 152:
Page 153 and 154:
Page 155 and 156:
Page 157 and 158:
Page 159 and 160:
Page 161 and 162:
Page 163 and 164:
Page 165 and 166:
Page 167 and 168:
Page 169 and 170:
Page 171 and 172:
Page 173 and 174:
Page 175 and 176:
Page 177 and 178:
Page 179 and 180:
Page 181 and 182:
Page 183 and 184: APPROVED PRESCRIPTION DRUG PRODUCTS
Page 189 and 190: PERCORTEN PIVALATE, DESOXYCORTICOST
Page 195: oAPPROVED PRESCRIPTION DRUG PRODUCT
Page 224 and 225: APPROVED PRESCRIPTIOH DRUG PRODUCTS
Page 243: APPROVED PRESCRIPTION DRUG PRODUCTS
Page 246 and 247: PRESCRIPTION DRUG PRODUCTS DEEMED A
show all

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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?