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

More documents

Recommendations

Info

APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST44DIGITOXININJECTABLE; INJECTIONCRYSTODIGINELI LILLYDIGOXIN200 UGM/MLDIHYDROERGOCORNINE MESYLATEj DIHYDROERGOCRISTINE MESYLATEjDIHYDROERGOCRYPTINE MESYLATETABLET; SUBLINGUALHYDROGENATED ERGOT ALKALO:tDSAA CHELSEA LABS 167 UGM;l67 UGH;l67 UGM * 333 UGM;AA333 UGM;33! UGMINJECTABLE; nlJECTIONDIGOXIHAP ELKINS-SINN/AHROBINS 250 UGM/MLAP VITARINE/WEST CHEM 500 UGMIZMLAP WYETH LABS/AMHO 250 UGH/MLLAHOXIHAP BURROUGHS WELLCOME 500 UGMIZHL100 UGM/MLDIHYDROERGOCRISTINE MESYLATEi *MULTIPLE*SEE DIHYDROERGOCORNINE MESYLATEi DIHYDROERGOCRISTINEMESYLATEj DIHYDROERGOCRYPTINE MESYLATEDIHYDROERGOCRYPTINE MESYLATE; *MULTIPLE*SEE DIHYDROERGOCORNINE MESYLATEi DIHYDROERGOCRISTINEMESYLATEj DIHYDROERGOCRYPTINE MESYLATE.f/;AAAAAAAAAAAAAAAAAAAAAAAAAADIHYDROERGOCORNINE MESYLATE; DIHYDROERGOCRISTINE MESYLATE;DIHYDROERGOCRYPTINE MESYLATETABLET; ORALHYDERGINESANDOZ PHARMSTABLET; SUBLINGUALC:tRCAHOLRIKER LABS/3M·167 UGM;l67 UGM;l67 UGM * 333 UGM;333 UGMi333 UGM167 UGM;167 UGM;167 UGM * 333 UGH;333 UGH;33! UGMDEAJ"R:tL-STMEAD JOHNSON/BM 333 UGM;33! UGH;333 UGHDIHYDROERGOTOXIHE MESYLATEPHARMADYNE LABSDIHYDROERGOTOXXHE METHAHESULFOHATEHEUN-NORWOOD LABS167 UGH;167 UGH;167 UGH * 333 UGH;333 UGH;!3! UGH167 UGH;167 UGH;167 UGH * 333 UGH;333 UGH;!!3 UGMLEDERLE LABS/AM CYAN 167 UGM;167 UGM;167 UGM * 333 UGM;333 UGH;333 UGHHYDERGXHESANDOZ PHARMSHYDROGEHATED ERGOT ALKALO:tDSBOLAR PH ARM167 UGM;167 UGM;167 UGH * 333 UGH;333 UGH;333 UGH167 UGH;167 UGH;167 UGH * 333 UGH;!33 UGH;33! UGHAPAPAPAPAPAPAPAADIHYDROERGOTAMINE MESYLATEINJECTABLE; INJECTIOND.H.E. 45SANDOZ PHARMSDIMENHYDRINATEIMG/MLINJECTABLE; INJECTIOND:tHEHHYDRIHATECARTER-GLOGAU LABS 50MG/MLCENTRAL PHARMACAL 5CHG/MLD-MPHARMACEUTICALS 50HG/MLELKINS-SINN/AHROBINS 5CMG/MLINT'L MEDICATION SYS 50MG/HLWYETH LABS/AMdODRAMAMIHESEARLE PHARMSSUPPOSITORY; RECTALORAtlAMINESEARLE PH ARMSTABLET; ORALD:tMEHHYDR:tHATEANABOLIC5CMG/ML50MG/ML100MG50MG
DIMENHYDlHNATEAPPROVED PRESCRIPTION DRUG PRODUCTS 45DRUG PRODUCT LISTDIPHENHYDRAMINE HYDROCHLORIDETABLET; ORALCAPSULE; ORALDIMEHHYDRIHATEBAXAA CHELSEA LABS SOMG AA MK LABS 2SMG If !mmBEHADRYLAA PARKE-DAVIS/W-L 2SMG If SOMGDIMERCAPRQLDIPHEHHYDRAMIHE HCLAA ANABOLIC 2SMG If !mmINJECTABLE; INJECTION AA BARR LABS ~ If SOMGBAL AA BELL PHARMACAL 2SMG If SOMGHYNSN WSTCTT DUNNING lOX AA BOLAR PHARM 2SMG M SOMGAA CHELSEA LABS 2SMG If !mmAA CORD LABS ~ If SOMGDIMETHYL SULFOXIDE AA DANBURY PHARMACAL 2SMG If SOMGAA GENERIC PH ARM/IVY 2SMG If SOMGSOLUTION; URETHRAL AA HEATHER DRUG ~ M SOMGRIMSO-SO AA ICN PHARMS 25MG If SOMGRESEARCH INDUSTRIES SOX AA LANNETT 25MG If !mmAA LEDERLE LABS/AM CYAN ~ If SOMGAA LEMMON PHARMACAL 2SMG If ~DINOPROST TROMEII-I~MINE AA NEWTRON PHARMS 2SMG If SOMGAA PHILIPS ROXANE LABS SOMGINJECTABLE; INJECTION AA PREMO PHARM LABS ~ If SOMGPROSTIN F2 ALPHA AA PRIVATE FORMULATIONS 2SMG If SOMGUPJOHN SMG/ML AA PUREPAC PHARM ~ If SOMGAA RICHLYN LABS 2SMG If ~AA STERI-MED/KETCHUM 2SMG M SOMGDINOPROSTONE(YROSTAG~ANDIN E-2) AA TOWNE PAULSEN ~ M SOMGAA WEST-WARD ~SUPPOSITORY; VAGINAL AA ZENITH LABS 2SMG If SOMGPROSTIN E2FEHYLHISTUPJOHN 20MG AA MALLARD SOMGSK-DIPHEHHYDRAMIHEAA SKF LABS 2SMG M SONG~IPHEMANIL METHYLSULFATEELIXIR; ORALTABLET; ORALBAXPRANTAL AA MK LABS 12.SMG/SMLSCHERING lOOMG BEHAORYLAA .PARKE-DAVIS/W-L 12.SMG/SML~DIPHENADIONE AA BAY LABS !2.SMG/SMLDIPHEHHYDRAMIHE HCLTABLET; ORAL AA BELL PHARMACAL 12.SMG/SMLDIPAXIN AA CM BUNDY 12.SMG/SMLUPJOHNSMG
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 55 and 56: j./APPROVED PRESCRIPTION DRUG PRODU
Page 65 and 66: -,----APPROVED PRESCRIPTION DRUG PR
Page 67 and 68: APPROVED PRESCRI~TIOHDRUG PRODUCTSD
Page 75: APPROVED PRESCRIPTION DRUG PRODUCTS
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 125 and 126: "~''''''-- .APPROVED PRESCRIPTION D
Page 127 and 128:
APPROVED PRESCRIPTION DRUG PRODUCTS
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:
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

Create successful ePaper yourself

Delete template?

Save as template?