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

More documents

Recommendations

Info

APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST110PREDNISONETABLET; ORALDELTA-DOHEBXDOHE LABS/HILES LABS 5HGDELTASONEBX UPJOHN 2.5HG * 5MG * 10HG * 20HG * 50HGFERNISONEBX FERNDALE LABS 5HGHETICORTENBX SCHERING IHG * 5HGBXORASONEROWELL LABS IHG * 5MG * 10HG * 20HG * 50HGPAt~-TRACEBX CORD LABS 5MGPARACORTBX PARKE-DAVIS/W-L 5MGPREDNICEN-MBX CENTRAL PHARMACAL 5MGPREDNISONEBX BARR LABS 5MG * 10MG * 20MG * 50HGBX BELL PHARMACAL 5MGBX CHELSEA LABS 5MG * 20MGBX CM BUNDY 5HGBX CORD LABS 5MG * 20MGBX DANBURY PHARMACAL 5MG * 10MG * 20MGBX FEDERAL PHARMACAL 5MGBX FIRST TEXAS PHARMS 5MGBX GENERIC PHARM/IVY 5MGBX HALSEY DRUG 5MGBX HEATHER DRUG 5MG * 10MG * 20MGBX HEUN-NORWOOD LABS 5MGBX ICN PHARMS 5MGBX INWOOD LABS/FOREST IMG * 2.5MG * 5MGBX KETCHUM LABS 5MGBX LANNETT 5MG * 20MGBX LEDERLE LABS/AM CYAN 5MGBX LEMHON PHARHACAL 5HGBX HK LABS 2.5MG * 5MGBX HYLAN PHARMS 5HGBX PANRAY/ORHONT DRUG IHG * 2.5MG * 5HGBX PHARHAVITE PHARMS 5HGBX PHILIPS ROXANE LABS 5HG * 10MG * 20MG * 50HGBX PHOENIX LABS 5HG * 20MGBX PREMO PHARH LABS 5MGBX PRIVATE FORMULATIONS 5HG * 20HGPREDNISONETABLET; ORALPREDNISONEBX PUREPAC PHARM 5MG * 10MG * 20HGBX REXALL DRUG 5MGBX RICHLYN LABS 5MGBX SPERTI DRUG PRODS IHG * 2.5MG * 5MGBX STAN LABS PHARM IMG * 2.5MG * 5MGBX STERI-HED/KETCHUM 20MGBX TABLICAPS 5HGBX TOWNE PAULSEN 2.5MG * 5MG * 20HGBX VITARINE/WEST CHEM 5MGBX WEST-WARD 5MG * 20HGBX ZENITH LABS 5MG * 10MG * 20MGBXSERVISONELEDERLE LABS/AM CYAN 5MGPRILOCAINE HYDROCHLORIDEINJECTABLE; INJECTIONCITANESTASTRA PHARM PRODS l~ * 2X * 3X * 4XPRILOCAINE HYDROCHLORIDE; *MULTIPLE*SEE EPINEPHRINE; PRILOCAINE HYDROCHLORIDEPRIMAQUINE PHOSPHATETABLET; ORALPRIMAQUINEWINTHROP L/STERLINGEQ 15MG BASEPRIMAQUINE PHOSPHATE; *MULTIPLE*SEE CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATEPRIMIDONESUSPENSION; ORALMYSOLINEAYERST LABS/AMHO250MG/5ML
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST111IPRIMIDONETABLET; ORALMYSOL:IHEAD AYERST LABS/AMHOABABADPR:IM:IDOHEBOLAR PHARMDANBURY PHARMACALLANNETTPROBENECID2S0MGSONG2S0MG2S0MG2S0MGTABLET; ORALBEHEM:IDAD NERCK SHARP & DOHME SOOMGPROBAlAHAB LANNETT SOOMGPROBEHECJ:DAB BEECHAM LABS SOOMGAB CHELSEA LABS SOOMGAB DANBURY PHARMACAL SOOMGAB LEDERLE LABS/AM CYAN SOOMGAB NYLAN PHARMS SOOHGPROBENECID; *MULTIPLE*SEE AMPICILLIN TRIHYDRATE; PROBENECIDSEE COLCHICINE; PROBENECIDPROBUCOLTABLET; ORALLORELCODOW PHARMSPROCAINAMIDE HYDROCHLORIDECAPSULE; ORALPROCAJ:HAMJ:DE HClAB BOLAR PHARMAB CHELSEA LABSAB DANBURY PHARMACAL250MG2S0MG lIf SOOMG2S0MG !II 37SMG • SOOMG2S0MG lIf 37SMG * SOOMGPROCAINAMIDE HYDROCHLORIDECAPSULE; ORALPROCA:IHAM:IDE HClAB LANNETT 2S0MG • SOOMGAB LEDERLE LABS/AN CYAN 2S0MG • 37SMG • SOOMGAB PARKE-DAVIS/W-L 2S0MG • SOOMGAB ZENITH LABS 2S0MG • 37SHG • SOOMGPROCAPAHAB PANRAY/ORMONT DRUG 2S0MGPROHESTYlAB ER SQUIBB AND SONS 2S0MG. 37SMG • SOOMGINJECTABLE; INJECTIONPRONESTYLER SQUIBB AND SONSTABLET; ORALPRONESTYLER SQUIBB AND SONSlOOMG/ML * 500MGIML2S0NG * 37SMG * SOOMGTABLET, CONTROLLED RELEASE; ORALPROCANPARKE-DAVIS/W-L 2S0MG * SOONGPROCAINE HYDROCHLORIDEINJECTABLE; INJECTIONHOVOCAJ:HAP BREON LABS/STERLING 11- * 21-lO/.PROCA:IHE HClAP ABBOTT LABS 1Z * 2?AP AM MCGAW/AM HOSP 11- * 2?AP BEL-MAR LABS 1? * 2?AP CARTER-GLOGAU 1? * 2?AP CUTTER LABS 1? • 2?AP D-M PHARMACEUTICALS 1? * 2?AP ELKINS-SINN/AHROBINS 1? • 2?AP INVENEX PHARMS/MOGUL 1? • 2?AP VITARINE/WEST CHEM 1?. 2?PROCAINE HYDROCHLORIDE; *HULTIPLE*SEE EPINEPHRINE; PROCAINE HYDROCHLORIDE
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: APPROVED PRESCRIPTION DRUG PRODUCTS
Page 95 and 96: '''"APPROVED PRESCRIPTION DRUG PROD
Page 97 and 98: ----..//APPROVED PRESCRIPTION DRUG
Page 125 and 126: "~''''''-- .APPROVED PRESCRIPTION D
Page 141: APPROVED PRESCRIPTION DRUG PRODUCTS
Page 189 and 190: PERCORTEN PIVALATE, DESOXYCORTICOST
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?