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

More documents

Recommendations

Info

APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST126SULFAMETHOXAZOLETABLET; ORALGAHTAHOLAS HOFFMANN-LA ROCHEGAHTAHOL-OSAS HOFFMANN-LA ROCHESULFAMETHOXAZOLEAS BOLAR PHARMAS CORD LABSSOOMGlGMSULFAMETHOXAZOLE; TRIMETHOPRIMSUSPENSION; ORALBACTRJ:MAS HOFFMANN-LA ROCHESACTRJ:M PEOJ:ATRJ:CAS HOFFMANN-LA ROCHESEPTRAAS BURROUGHS WELLCOMETABLET; ORALSACTRJ:MAS HOFFMANN-LA ROCHESACTRIM OSAS HOFFtIANN-LA ROCHESEPTRAAS BURROUGHS WELLCOMESEPTRA OSAS BURROUGHS WELLCOMESULFAPHENAZOLESUSPENSION; ORALSULFABIDPURDUE FREDERICKTABLET; ORALSULFABIDPURDUE FREDERICKSULFAPYRIDINETABLET; ORALSULFAPYRIDINEELI LILLYSOOMG *' lGMSOOMG200MG/SMLl40MG/SML200MG/SMLl40MG/SML200MG/SMLl40MG/SML400MGl80MG800MG;!60MG400MG;80MG800MGll60MG500MG/5MLSOOMGSOOMGSULFASALAZINETABLET; ORALAZULFIDJ:HEAS PHARMACIA LABS SOOMGS.A.S.-SOOAS ROWELL LABSSOOMGSULFASALAZJ:HEBP BOLAR PHARM SOOMGBP CHELSEA LABS SOOMGAS LEDERLE LABS/AM CYAN SOOMGSULFATHIAZOLE; *MULTIPLE*SEE SULFABENZAMIDE; SULFACETAMIDE; SULFATHIAZOLE; UREASEE SULFABENZAMIDE; SULFACETAMIDE; SULFATHIAZOLESULFINPYRAZONECAPSULE; ORALANTURANECIBA PHARMTABLET; ORALANTURANECIBA PHARMSULFISOXAZOLE200MGIOOMGCREAM; VAGINALGAHTRJ:SJ:HAT HOFFMANN-LA ROCHE IOi!KORO-SULFAT HOLLAND-RANTOS IOi!TABLET; ORALGAHTRISIHAS HOFFMANN-LA ROCHE SOOMGSK-SOXAZOLEAS SKF LABS SOOMGSOSOLAS MK LABS SOOMGSTAHSIHAS STAN LABS PHARM SOOMG
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST127SULFISOXAZOLETABLET; ORALSULFALARAD PARKE-DAVIS/W-L SOOMGSULFISOXAZOLEAD BARR LABS SOOMGBP CHELSEA LABS 500MGAD CORD LABS SOOMGAD HEATHER DRUG SOOMGAD ICN PHARMS SOOMGAD LANNETT SOOMGAD LEDERLE LABS/AM CYAN SOOMGAD MYLAN PHARMS SOOMGAD PHILIPS ROXANE LABS SOOMGAD RICHL YN L.A.BS SOOHGAD WEST-WARD SOOMGAD ZENITH LABS SOOMGSULSOXIHAB REID-PROVIDENT LABS SOOMGSULFISOXAZOLE DIOLAMINEOINTMENT; OPHTHALMICGANTRISINHOFFMANN-LA ROCHE4XSOLUTION/DROPS; OPHTHALMICGANTRISINHOFFMANN-LA ROCHE 4XSULFOXONE SODIUMTABLET, ENTERIC COATED; ORALDIASONE SODIUMABBOTT LABS165MGSULFUR; *MULTIPLE*SEE BENTONITE; SULFURSULFISOXAZOLE ACETYLEMULSION; ORALLIPO GANTRISINHOFFMANN-LA ROCHESUSPENSION; ORALGANTRISIN PEDIATRICHOFFMANN-LA ROCHESYRUP; ORALGANTRISINHOFFMANN-LA ROCHEEQ IGM BASE/5MLEQ 500MG BASE/5MLEQ 500MG BASE/5MLSULFISOXAZOLE ACETYL; *MUL TIPLE*SEE ERYTHROMYCIN ETHYLSUCCINATEj SULFISOXAZOLE ACETYLSULFISOXAZOLE DIOLAMINEINJECTABLE; INJECTIONGANTRISINHOFFMANN-LA ROCHE400MG/MLSULINDACTABLET; ORALCLINORILMERCK SHARP & DOHMESUTILAINSOINTMENT; TOPICALTRAVASETRAVENOL LABSTALBUTALTABLET; ORALLOTUS ATEWINTHROP LISTER LINGTAMOXIFEN CITRATETABLET; ORALNOLVADEXICI AMERICAS150MG * 200MG82.000 UNITS/GM120MGEQ 10MG BASE
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: APPROVED PRESCRIPTION DRUG PRODUCTS
Page 125 and 126: "~''''''-- .APPROVED PRESCRIPTION D
Page 157: APPROVED PRESCRIPTION DRUG PRODUCTS
Page 189 and 190: PERCORTEN PIVALATE, DESOXYCORTICOST
Page 195: oAPPROVED PRESCRIPTION DRUG PRODUCT
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?