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

More documents

Recommendations

Info

APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST86METHARBITAlTABLET; ORALGEMONIlABBOTT LABSMETHAZOLAMIDElOOMGMETHICILLIN SODIUM MONOHYDRATEINJECTABLE; INJECTIONSTAPHCILlIHAP " BRISTOL LABS/BMAPAPEQ 900MG BASE/VIAL *Eg 3.6GM BASE/VIAL *Eg 5.4GM BASE/VIALTABLET; ORALNEPTAZANELEDERLE LABS/AM CYAN 50MGMETHDILAZINE HYDROCHLORIDESYRUP; ORALTACARYlWESTWOOD PHARMSTABLET; ORALTACARYlWESTWOOD PHARMSTABLET, CHEWABLE; ORALTACARYlWESTWOOD PH ARMSMETHENAMINE HIPPURATE4MG/5MLSMG3.6MGTABLET; ORALHIPREXA8 MERRELL-NATIONALUREXIGMAB RIKER LABS/3M IGMMETHICILLIN SODIUM MONOHYDRATEINJECTABLE; INJECTIONCElBEHIHAP BEECHAM LABSAPAPEQ 900MG BASE/VIAL *Eg 3.6GM BASE/VIAL *Eg 5.4GM BASE/VIALEQ 1.SGM BASE/VIAL *EQ 9GM BASE/VIALMETHIMAZOLETABLET; ORALTAPAZOLEELI LILLYMETHIXENE HYDROCHLORIDETABLET; ORALTRESTDORSEY LABS/SANDOZMETHOCARBAMOLINJECTABLE; INJECTIONMETHOCARBAMOlAP CARTER-GLOGAURCBAXIHAP AH ROBINSTABLET; ORALDElAXIHAA FERNDALE LABSFORBAXIHAA FOREST LABSMETHOCARBAMOlAA BARR LABSAA BOLAR PHARMAA CHELSEA LABSAA CORD LABSAA DANBURY PHARMACALAA GENERIC PHARM/IVYAA HEATHER DRUGAA INWOOD LABS/FORESTAA KV PHARMACEUTICAL5MG If lOMGIMGlOOMG/MllOOMG/Ml500MG750MG500MG * 750MG500MG * 750MG500MG * 750MG500MG * liQtl§500MG * 750MG500MG * 750MG500MG * 750MG500MG500MG * 750MG
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST87METHOCARBAMOLTABLET; ORALMETHOCA~BAMOLAA LANNETT 750MGAA LEDERLE LABS/AM CYAN 500MG M 750MGAA MYLAN PH ARMS 500MG M 750MGAA PAR PHARM500MG M 750MGAA PUREPAC PHARM 500MG M 750MGAA REID-PROVIDENT LABS 500MG M 75mlGAA RICHLYN LABS500MG M 750MGAA TABLICAPS500MG M 750MGAA WEST-WARD500MG M 750MGAA ZENITH LABS500MG M 750MGROBAX:IHAA AH ROBINS500MG M 750MGMETHOCARBAMOL; *MULTIPLE*SEE ASPIRIN; METHOCARBAMOLMETHOHEXITAL SODIUMINJECTABLE; INJECTIONBREVITAL SODIUMELI LILLYMETHOTREXATETABLET; ORALMETHOTREXATELEDERLE LABS/AM CYAN 2.5MGMETHOTREXATE SODIUMINJECTABLE; INJECTIONMETHOTREXATEAP LEDERLE LABS/AM CYANAPAPAPMEXATEBRISTOL LABS/BM500MG/AMP * 2.5GM/AMP * 5GM/AMPE~ 20MG BASE/V:IAL ME~ 50MG BASE/V:IALEQ 2.5MG BASE/ML * EQ 25MG BASE/ML *EQ 5MG BASE/VIALE~ 20MB BASE/V:IAL *EQ 50MG BASE/V:IALMETHOTREXATE SODIUMINJECTABLE; INJECTIONMEXATEBRISTOL LABS/BMMETHOTRIMEPRAZINEINJECTABLE; INJECTIONLEVOPRotlELEDERLE LABS/AM CYAN 20MG/MLMETHOXAMINE HYDROCHLORIDEINJECTABLE; INJECTIONVASOXYLBURROUGHS WELLCOMEMETHOXSALENLOTION; TOPICALOXSORALENPAUL B ELDERMETHOXYFLURANESOLUTION; INHALATIONPENTHRANEABBOTT LABSMETHSCOPOLAMINE BROMIDETABLET; ORALMETHSCOPOLAM:IHE BROM:IDEAA PRIVATE FORMULATIONS 2.5MGPAM:IHEAA UPJOHN 2.5MGMETHSUXIMIDECAPSULE; ORALCELONTINPARKE-DAVIS/W-LEQ lOOMG BASE/VIALlOMG/ML * 20MG/ML17099.970l50MG * 300MG
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: APPROVED PRESCRIPTION DRUG PRODUCTS
Page 77 and 78: DIMENHYDlHNATEAPPROVED PRESCRIPTION
Page 81 and 82: ------"".,APPROVED PRESCRIPTION DRU
Page 91 and 92: APPROVED ¥RESCRIPTION DRUG PRODUCT
Page 95 and 96: '''"APPROVED PRESCRIPTION DRUG PROD
Page 97 and 98: ----..//APPROVED PRESCRIPTION DRUG
Page 117: APPROVED PRESCRIPTION DRUG PRODUCTS
Page 125 and 126: "~''''''-- .APPROVED PRESCRIPTION D
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:
Page 185 and 186:
Page 187 and 188:
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

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

Delete template?

Save as template?