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

More documents

Recommendations

Info

APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST100PENICILLIN G POTASSIUMPOWDER FOR RECONSTITUTION; ORALPEHICILLIH G POTASSIUMAA BIOCRAFT LABS 2002000 UHITS/5ML *AA 2502000 UHITS/5ML *AA4002000 UHITS/5MLAA MYLAN PHARMS 2002000 UHITS/5ML *AA 2502000 UHITS/5ML *AA4002000 UHITS/5MLAA PUREPAC PHARM 2502000 UHITS/5ML *AA4002000 UHITS/5HLPEHTY-DS '200'AA ER SQUIBB AND SONS 2002000 UHITS/5MLPEHT:IDS '400'AA ER SQUIBB AND SONS 4002000 UHITS/5MLPFIZERPEH GAA PFIZER LABS 400,000 UHITS/5MLTABLET; ORALPEHICILLIH G POTASSIUMAB BIOCRAFT LABS 2002000 UHITS * 250,000 UHITS *AB4002000 UHITS * 500,000 UHITSAB DISTA PRODS/LILLY 250,000 UHITSAB ER SQUIBB AND SONS 2502000 UHITSAB JOHN D COPANOS 100,000 UHITS * 200.000 UHITS *AB 250,000 UNITS * 400,000 UHITS *AB500,000 UHITSAB LEDERLE LABS/AM CYAN 4002000 UHITSAB MYLAN PHARMS 200 2000 UHITS * 2502000 UHITS *AB4002000 UNITS * 800 2000 UHITSAB PUREPAC PHARM 2002000 UHITS * 250,000 UHITS *AB4002000 UNITSAB WYETH LABS/AMHO 200 2000 UNITS * 250,000 UHITS *AB4002000 UHITSAB ZENITH LABS 400,000 UNITSPEHTIDS '200'AB ER SQUIBB AND SONS 2002000 UNITSPENTIDS '250'AB ER SQUIBB AND SONS 250,000 UHITSPEHTIDS '400'AB ER SQUIBB AND SONS 4002000 UHITSPEHTIDS '800'AB ER SQUIBB AND SONS 800 2000 UNITSPFIZERPE~AB PFIZER LABS 1002°00 UHITS 200,000 UHITS AB 250,000 UHITS * 400,000 UHITS *AB800,000 UHITSPENICILLIN G POTASSIUMTABLET; ORALPFIZERPEH GPFIZER LABSPENICILLIN G PROCAINEINJECTABLE; INJECTIONDURACILLIH A.S.AP ELI LILLYPENICILLIH G PROCAINEAP JOHN D COPANOSAP PARKE-DAVIS/W-LPFIZER LABSAPAPPFIZERPEH-ASPFIZER LABSWYCJ:LLIHWYETH LABS/AMHO50,000 UNITS3002000 UHITS/ML300,000 UHITS/ML * 600,000 UHITSIML3002000 UHITS/ML300,000 UNITS/VIAL *1,500,000 UNITS/VIAL300,000 UHITS/ML * 600,000 UHITS/ML1,200,000 UNITS/ML300,000 UHITS/ML * 600,000 UHITS/MLPENICILLIN G PROCAINE; *MULTIPLE*SEE PENICILLIN G BENZATHINEj PENICILLIN G PROCAINEPENICILLIN G SODIUMINJECTABLE; INJECTIONPENICILLIN G SODIUMSQUIBB/ITALYUPJOHNPENICILLIN V5,000,000 UNITS/VIAL1,000,000 UNITS/VIALPOWDER FOR RECONSTITUTION; ORALV-CILLINELI LILLY125MG/600 ULPENICILLIN V POTASSIUMPOWDER FOR RECONSTITUTION; ORALBETAPEH-VKAA BRISTOL LABS/BM EQ 125MG BASE/5ML *AAEQ 250MB BASE/5ML
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST101PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMPOWDER FOR RECONSTITUTION; ORALTABLET; ORALLEDERCILLrH VKPEHICILLIH V POTASSIUMAA LEDERLE LABS/AM CYAN E9 125MG BASE/SML * AB MYLAN PHARMSE9 250MG BASE * E9 500MG BASEPUREPAC PHARM E9 12SMG BASE * E~ 250MG BASE *E9 500MG BASEAAPEH-VEE KE9 250MG BASE/5ML ABABAAAAE9 125MG BASE/5MLE9 250MG BASE/5MLABABWYETH LABS/AMHO * ZENITH LABSE9 125MG BASE * E~ 250MG BASE *EQ SOOMG BASEPEHAPAR-VKPENICILLIH VKAA E~ BIOCRAFT LABSE~ 2S0MGBASE *E~ SOOMG BASEAA E9 PF:tzERPEH VKPEHICILLIH V POTASSIUM AB PFIZER LABSE~ 2S0MG BASE * EQ SOOMG BASEPARKE-DAVIS/W-L 12SMG BASE/SHL *250MG BASE/5MLABAA BIOCRAFT LABS E9 125MG BASE/SML * UnCILLIH VKAA E9 2S0MG BASE/SML AB UPJOHNE~ 2S0MG BASE * EQ SOOMG BASEAB JOHN D COPANOS E9 125MG BASE/5ML * V-CILLIH KAB E9 250MG BASE/5ML AB ELI LILLYE9 12SMG BASE * EQ 2S0MG BASE *AA MYLAN PHARMS E9 125MG BASE/5ML * ABEQ 500HG BASEAA E9 2S0MG BASE/SHL VEETIDS '250'AA PUREPAC PHARM E9 125MG BASE/5ML * AB ER SQUIBB AND SONS EQ 250MG BASEAA E9 250MG BASE/SHL VEETIOS 'SOO'PF:tzERPEH VK AB ER SQUIBB AND SONS EQ 500MG BASEAA PFIZER LABS E9 12SMG BASE/SML *AAE9 2S0MG BASE/SMLUTICILLIH VKPENTAGASTRINAA UPJOHN E9 125MG BASE/5ML *AA E9 2S0HG BASE/5ML INJECTABLE; INJECTIONV-CILLIH KPEPTAVLCNAA ELI LHLY E9 12SMG BASE/SML * AYERST LABS/AMHO 250 UGM/MLAAEQ 250MG BASE/5HLVEETIOS '12S'AA ER SQUIBB AND SONS EGI 125MG BASE/5ML PENTAZOCINE HYDROCHLORIDEVEETl"OS '2S0'AA ER SQUIBB AND SONS E9 2S0MG BASE/5ML TABLET; ORALTALWINTABLET; ORALWINTHROP L/STERLING EQ SOMG BASEBETAPEH-VKAB BRISTOL LABS/BM E9 2S0MG BASE * EQ 500MG BASE -PENTAZOCINE HYDROCHLORIDE; *MULTIPLE*SEE ASPIRIN; PENTAZOCINE HYDROCHLORIDEABLEDERCILLIH VKLEDERLE LABS/AM CYAN EQ 2S0MG BASE * EQ 500MG BASEPEH-VEE KAB WYETH LABS/AMHO E9 12SMG BASE * EQ 2S0MG BASE *ASPEHAPAR-VKE9 SOOMG BASE PENTAZOCINE LACTATEAB PARKE-DAVIS/W-L E9 250MG BASE * EQ 500MG BASE INJECTABLE; INJECTIONPEHICILLIH V POTASSIUMTALWINAB JOHN D COPANOS ~Q 2S0MG BASE * EQ SOOMG BASE WINTHROP LISTER LING EGI 30MG BASE/ML
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: APPROVED PRESCRIPTION DRUG PRODUCTS
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 131: APPROVED PRESCRIPTION DRUG PRODUCTS
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?