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

More documents

Recommendations

Info

APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX36USV DEV/PRDORIDEN, GLUTETHIMIDEUSV LA~SDElU-REGROTON, CHLORTHALIDONEHYGROTON. CHLORTHALIDONEPERTOFRANE, DESIPRAMINE HYDROCHLORIDEREGROTON, CHLORTHALIDONEUSV PHARMAQUASOL A, VITAMIN AAZOLID, PHENYLBUTAZONEVORANIL, CLORTERMINE HYDROCHLORIDE** V **VALE CHEM:tCALAMINOPHYllINE, AMINOPHYllINERAUVAl, RAUWOLFIA SERPENTINASERPATE, RESERPINESODIUM BUTABARBITAl, BUTABARBITAL SODIL~TRIPLE SULFOID, TRISULFAPYRIMIDINESVESTAL LABS/CHEMEDSEPTI-SOFT, HEXACHLOROPHENESEPTISOl, HEXACHLOROPHENECtlEI1ALPHAZINE, PHENDIMETRAZINE TARTRATEAMINOPHYLLINE, AlUNOPHYLLINEBETHANECHOl CHLORIDE, BETHANECHOL CHLORIDECALCIUM GLUCEPTATE, CALCIUM GlUCEPTATECHlORPHENIRAMINE MALEATE, CHlORPHENIRAMINE MALEATECORTISONE ACETATE, CORTISONE ACETATECYANOCOBALAMIN, CYANOCOBALAMINDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATEDIGOXIN, DIGOXINDIPHENHYDRAMINE HCL, DIPHENHYDRAMINE HYDROCHLORIDEHISTAMINE PHOSPHATE, HISTAMINE PHOSPHATEIPRENOL, ISOPROTERENOL HYDROCHLORIDElIDOCAINE HCl, lIDOCAINE HYDROCHLORIDEMEPERIDINE HCl, MEPERIDINE HYDROCHLORIDENEOMYCIN SULFATE, NEOliYCIN SULFATEPENTOBARBITAL SODIUM, PENTOBARBITAL SODIUMPHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATEPHENTERMINE HCL, PHENTERMINE HYDROCHLORIDEPHENYTOIN SODIUM, PHENYTOIN SODIU~IPOTASSIUM CHLORIDE, POTASSIUM CHLORIDEPREDNISONE, PREDNISONEPROCAINE HCl, PROCAINE HYDROCHLORIDEPYRIDOXINE HCL, PYRIDOXINE HYDROCHLORIDEQUINIDINE SULFATE, QUINIDINE SULFATEVIT~,RIHE/~JF.STv:tT ..!'!~r'lF./W!STtHEMSECOBARBITAL SODIUM, SECOBARBITAL SODIUMSERPIVITE, RESERPINESUPERCIDIN, ISONIAZIDTHIAMINE HCl, THIAMINE HYDROCHLORIDEVITAMIN 0, ERGOCALCIFEROLWESCOIiEX, HEXACHLOROPHENEWESTADONE, METHADONE HYDROCHLORIDE** 14 **WALLACE LABS/C-Ir!AQUATENSEN, METHYCLOTHIAZIDEDEPEN 250, PENICILLAMINEDIPHENOXYlATE HCl AND ATROPINE SULFATE, ATROPINE SULFATEDIUTENSEN-R, METHYCLOTHIAZIDELUFYLLIN, DYPHYlLINEMYLAXEN, HEXAFLUORENIl1M BROMIDENEOPASALATE, AMINOSALICYLIC ACIDRONDOMYCIN, METHACYClINE HYDROCHLORIDESOfiA, CARISOPRODOLSOIH L YN, SULFACHLORPYRIDAZINEUNITENSEN, CRYPTENAMINE ACETATES~~ITENSEN, CRYPTENAMINE TA~~ATESVOSOL, ACETIC ACID, GLACIALVOSOL HC, ACETIC ACID, GLACIALWAMPOCAP, NIACINWAI.LACE PtlMI11!'i/C-WDORMATE, MEBUTAMATEMEPROSPAN, MEPROBAMATEMICRAININ, ASPIRINMIlPREM-200, ESTROGENS, CONJUGATEDMIlPREM-400, ESTROGENS, CONJUGATEDMIlTOWN, MEPROBAMATESOMA COMPOUND, CAFFEINESOMA COMPOUND WI CODEINE, CAFFEINEWARREN-TEED/AURIAKAON-CL, POTASSIUM CHLORIDECtrF.M PRODSWESCOHEX, HEXACHLOROPHENEWESTASEPT, HEXACHLOROPHENE~IESTWEST-WARDAtIINOPHYLLINE, AMINOPHYLLINEBUTABARBITAl SODIUM" BUTABARBITAl SODIUMBUTAlBITAl WI APC, ASPIRINCHLORDIAZEPOXIDE HCl, CHLORDIAZEPOXIDE HYDROCHLORIDECHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATECHLORPHENIRAMINE MALEATE, CHlORPHENIRAMINE MALEATE
APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER IHDEX37WEST-W,~RDCORTISONE ACETATE, CORTISONE ACETATECYANOCOBALAMIN, CYANOCOBALAMINDEXAMETHASONE, DEXAMETR~SONEDIETHYLSTILBESTROL, DIETHYLSTILBESTROLDIFHENHYDRAMHlE HCL, DIPHENHYDRAMINE HYDROCHLORIDEFOLIC ACID, FOLIC ACIDHYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDEHYDROCORTISONE, HYDROCORTISONEISONIAZID, ISONIAZIDMEPROBAMATE, MEPROBA~tATEMETHOCARBA~IOL, !·tETHOCARBAMOLMETHYLTESTOSTERONE, METHYLTESTOSTERONENIACIN, NIACINOXYTETRACYCLINE HCL, OXYTETRACYCLINE HYDROCHLORIDEPREDNISOLONE, PREDNISOLONEPREDNISONE, PREDNISONEPROPOXYPHENE HCL, PROPOXYPHENE HYDROCHLORIDEPROPYLTHIOURACIL, PROPYLTHIOURACILQUINIDINE SULFATE, QUINIDINE SULFATERESERPINE, RESERPINESODIUM, BUTABARBITAL, BUTABARBITAL SODIUMSODIUM PENTOBARBITAL, PENTOBARBITAL SODIUMSODIU~I SECOBARBITAL, SECOB.tIRBITAL SODIUMSULFISOXAZOLE, SULFISOXAZOLETETRACYCLINE, TETRACYCLINETETRACYCLINE HCL, TETRACYCLINE HYDROCHLORIDETHEOPHYLLINE, THEOPHYLLINETRIPELENNAMINE HCL, TRIPELENNAMINE HYDROCHLORIDEVITAMIN A, VITAMIN AVITAHIH A, VITAMIN A PALMITATEVITAMIN 0, ERGOCALCIFEROLI>lImnrm RES LABSCHLORDIAZEPOXIDE HCL, CHLORDIAZEPOXIDE HYDROCHLORIDECHLORPROMAZINE HCL, CHLORPROMAZINE HYDROCHLORIDEMETHYLTESTOSTERONE, METHYL TESTOSTERm.EPHENTERMINE HCL, PHENTERMINE HYDROCHLORIDEWESTNn!'lD "HARMSCAPITROL, CHLOROXINEHALOTEX, HALOPROGINTACARYL, HETHDILAZINE HYDROCHLORIDEI~ESTCORT, HYDROCORTISONE VALERATEWlfARTtm LA!3SVITAMIN A, VITAMIN A PALMITATEWILLIAM P rOYTHRESSBENSULFOID, BENTONITEWIHTH~OPL/STE~L!HSAMIPAQUE, METRIZAMIDEARALEN HCL, CHLOROQUINE HYDROCHLORIDEARALEN PHOSPHATE, CHLOROQUINE PHOSPHATEARALEN PHOSPHATE WI PRIMAQUINE PHOSPHATE, CHLOROQUINEPHOSPHATEBILOPAQUE SODIUM, TYROPANOATE SODIUMDANOCRINE, DANAZOLDEttEROL, MEPERIDINE HYDROCHLORIDEDRISDOL, ERGOCALCIFEROLHYPAQUE, DIATRIZOATE MEGLUMINEHYPAQUE, DIATRIZOATE SODIUMHYPAQUE-CYSTO, DIATRIZOATE MEGLUMINEHYPAQUE-M, DIATRIZOATE MEGLUtlINEHYPAQUE-76, DIATRIZOATE MEGLUMINEISOPAQUE 280, CALCIUMISOPAQUE 440, CALCIUM METRIZOATELOTUSATE, TALBUTALMYTELASE, AMBENONIUM CHLORIDENEGGRAM, NALIDIXIC ACIDPHISO-SCRUB, HEXACHLOROPHENEPHISOHEX, ~XACHLOROPHENEPLAQUEtHL .. ' HYDROXYCHLOROQUINE SULFATEPRIMAQUniE, PRIMAQUINE PHOSPHATEPROMETHAZINE HCL, PROMETHAZINE HYDROCHLORIDESULFAMYLON, MAFENIDE ACETATETALWIN, PEtlTAZOCltlE HYDROCHLORIDETALWIN, PENTAZOCINE LACTATETALWIN COMPOUND, ASPIRINTELEPAQUE, IOPANOIC ACIDP/STERLINSBRYREL, PIPERAZINE CITRATEWIHT~OPWYETH LtlI3S/AI1NOATIVAN, LORAZEPAMBICILLIN, PENICILLIN G BENZATHINEBICILLIN C-R, PENICILLIN G BENZATHINEBICILLIN L-A, PENICILLIN G BENZATHINECHLORPROMAZINE HCL, CHLORPROMAZINE HYDROCHLORIDECY f.tlOCOBALAMW, CYANOCOBALAMINCYCLAPEN, CYCLACILLINDEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATEDIGOXIN, DIGOXINDIMENHYDRINATE, DIMENHYDRINATEDIPHENHYDRAtlINE HCL, DIPHENHYDRAMINE HYDROCHLORIDEEQUAtHL, MEPROBAMATEHEPARIN SODIUM, HEPARIN SODIUMHEPARIN SODIUM IN NORMAL SALINE, HEPARIN SODIUM
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: 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?