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

More documents

Recommendations

Info

APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST112PROCAINE HYDROCHLORIDE; *MULTIPLE*SEE LEVARTERENOL BITARTRATE; PROCAINE HYDROCHLORIDE;PROPOXYCAINE HYDROCHLORIDESEE LEVONORDEFRIN; PROCAINE HYDROCHLORIDE; PROPOXYCAINEHYDROCHLORIDEAPAPPROCAINE MERETHOXYLLINE; THEOPHYLLINEINJECTABLE; INJECTIONDICURIN PROCAINEELI LILLYPROCARBAZINE HYDROCHLORIDECAPSULE; ORALMATULANEHOFFMANN-LA ROCHEPROCHLORPERAZINESUPPOSITORY; RECTALCOMPAZINESKF LABSPROCHLORPERAZINE EDISYLATECONCENTRATE; ORALCOMPAZINESKF LABS100MGIML;50MG/MLEQ 50MG BASE2.5MG * 5MG * 25MGEQ 10MG BASEIMLINJECTABLE; INJECTIONCOMPAZIHESKF LABSEq 5MG BASE/i'lLPROCHLORPERAZIHE EDISYLATEWYETH LABS/AMHO Eg 5MG BASE/i'lLSYRUP; ORALCOMPAZINESKF LABSEQ 5MG BASE/5MLPROCHLORPERAZINE MALEATECAPSULE, CONTROLLED RELEASE; ORALCOMPAZINESKF LABSEQ lOMG BASE * EQ 15MG BASE *EQ 30MG BASE * EQ 75MG BASETABLET; ORALCOMPAZIHEAB SKF LABSABPROCHLORPERAZIHEAB BOLAR PHARMABPROCYCLIDINE HYDROCHLORIDETABLET; ORALKEMADRINBURROUGHS WELLCOMEPROGESTERONEINJECTABLE; INJECTIONPROGESTEROHEAO CARTER-GLOGAU LABSAO ELI LILLYEQ 5MB BASE M EQ 10MB BASE MEQ 25MB BASEEq 5MB BASE M EQ 10MG BASE MEQ 25MG BASE2MG * 5MG50MG/ML50MG/I'IL25MG/MLINSERT, CONTROLLED RELEASE; INTRAUTERINEPROGESTASERTALZA38MGPROMAZINE HYDROCHLORIDECONCENTRATE; ORALSPARINEWYETH LABS/AMHOINJECTABLE; INJECTIONPROMAZIHE HCLAP CARTER-GLOGAU LABSSPARIHEAP WYETH LABS/AMHO30MG/ML * lOOMG/ML25MG/ML M 50MG/ML25MG/Ml M 50MG/ML~"
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST113PROMAZINE HYDROCHLORIDESYRUP; ORALSPARINEWYETH LABS/ANHOTABLET; ORALSPARINEWYETH LABS/AMHOPROMETHAZINE HYDROCHLORIDEINJECTABLE; INJECTIONPHEHCEH-SOAP CENTRAL PHARMACALAPAPAPAPAPAPAPAPAPPHEHERG~HSUPPOSITORY; RECTALPHENERGANWYETH LABS/AMHOSYRUP; ORALPHEHERGAHAA WYETH LABS/AMHOPHEHERGAH FORTISAA WYETH LABS/AMHOAt.AAAAI'RO~IETHTABLET; ORALLEMPROMETHBP LEMMON PHARMACALIOMG/5MLIOMG * 25MG * SOMG * IOOMG * 200NGSOMG/MLWYETH LABS/AMHO ZSMG/ML * SOMG/MLPROMETHAZINE HClCARTER-GLOGAU LABSD-M PHARMACEUTICALSELKINS-SINN/AHROBINSKNOLL PHARMMAURRY BIOLOGICALWINTHROP LISTER LINGZIPAH-ZSBYK-GULDEN25MG/HLZIPAH-50BYK-GULDENSOMG/MLZSMG/ML * SOMG/MLZSNG/ML * SONG/MLZ5NG/NL * SONG/NL2SNG/NL * SONG/ML2SNG/NL * SONG/ML25MG/ML * SONG/ML12.5NG * 25NG * SONG6.2SMG/SML25MG/SMLNATL PHARM tIFG/BARRE 6.2SNG/SML If 2SHG/SMLPROMETHAZIHE HClHEUN-NORWQOD LABS 6.2SMG/SML If 2SMG/SMLTOWNE PAULSEN §.2SMG/SML2SNG * SONGPROMETHAZINE HYDROCHLORIDETABLET; ORALPHENERGANBP WYETH LABS/AMHOPROMETHAZINE HCL12.5MG If 25NG If 50NGBP BARR LABSBP BOLAR PHARMBP CHELSEA LABSBP CORD LABSBP DANBURY PHARMACALBP GENERIC PHARM/IVYBP LANNETTBP LEDERLE LABS/AM CYANBP PRIVATE FORMULATIONSBP RICHLYN LABSBP TABLICAPSBP ZENITH LABSREtlSEDBP ENDO LABS/DUPONT 25MG * SONGZIPAN-2SBP SAVAGE/BYK-GULDEN 2SNGZIPAN-SOBP SAVAGE/BYK-GULDEN SONG12.5MG * 25NG * SOMG12.5MG If 25MG * 50MG12.5MG * 25MG * SOMG12.5NG If 2SNG If SONG12.5NG * 25MG * SOMG12.5NG If 25NG If 50NG12.5MG * 25NG If 50NG25NG * 50NG12.5NG * 25NG25NG12.5NG * 25NG12.SNG * 2SMG * SOMGPROMETHAZINE HYDROCHLORIDE; *MULTIPLE*SEE MEPERIDINE HYDROCHLORIDE; PRONETHAZINE HYDROCHLORIDEAAAt.AAAt.AAAt.MPROPANTHELINE BROMIDEINJECTABLE; INJECTIONPRO-BANTHINESEARLETABLET; ORALI'RO-BAHTHIHESEARLEPROPAHTHELIHE BROMIDEBOLAR PHARMCORD LABSDANBURY PHARMACAL30NG/VIALISMGISMGISMGHEATHER DRUGISMGLEDERLE LABS/AM CYAN ISMGNYlAN PHARMSISMG7.SMG * ISMG
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 143: APPROVED PRESCRIPTION DRUG PRODUCTS
Page 189 and 190: PERCORTEN PIVALATE, DESOXYCORTICOST
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?