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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST140UREAVIDARABINEAPINJECTABLE; INJECTIONUREAPH:ILABBOTT LABS4.0GM/BOTOINTMENT; OPHTHALMICVIR A-APARKE-DAVIS/W-L37.UREA; *MULTIPLE*SEE HYDROCORTISONE ACETATE; UREASEE HYDROCORTISONE; UREASEE INVERT SUGAR; UREASEE SULFABENZAMIDEj SULFACETAMIDE; SULFATHIAZOLE; UREAVIDARABINE MONOHYDRATEINJECTABLE; INJECTIONVIRA-APARKE-DAVIS/W-LEQ l87.4MG BASE/MLVALPROATE SODIUMVINBLASTINE SULFATESYRUP; ORALDEPAKENEABBOTT LABSEQ 2S0MG BASE/SMLINJECTABLE; INJECTIONVELBANELI LILLY10MG/AMPVALPROIC ACIDVINCRISTINE SULFATECAPSULE; ORALDEPAKENEABBOTT LABS2S0MGINJECTABLE; INJECTIONONCOVINELI LILLYlMG/AMP * SMG/AMPVANCOMYCIN HYDROCHLORIDEVIOMYCIN SULFATEINJECTABLE; INJECTIONVANCOCIN HCLELI LILLYEQ SOOMG BASE/VIALINJECTABLE; INJECTIONV.IOCIN SULFATEPFIZER LABSEQ lGN BASE/VIAL * EQ SGN BASE/VIALPOWDER FOR RECONSTITUTION; ORALVANCOCIN HCLELI LILLYEQ SOONG BASE/6MLVASOPRESSIN TANNATEINJECTABLE; INJECTIONPITRESSIN TANNATEPARKE-DAVIS/W-lS UNITS/MlVITAMIN ACAPSULE; ORALAgUASOL AAA USV PHARNVI:TAMI:H A5°2°°0 UH:ITS2S,000 UNITSAA ARCUM PHARM 5°2°°0 UHI:TSAA CHASE CHEMICAL 5°2°°0 UH:rTSAA LEDERLE LABS/AM CYAN 5°2°00 UH:rTSAA PHARMACAPS 50.000 UHI:TS
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST141VITAMIN ACAPSULE; ORALVITAMZH AAA RICHLYN LABSAA STAN LABS PHARMAA WEST-WARDAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAINJECTABLE; INJECTIONAQUASOL AUSV PHARMVITAMIN A PALMITATECAPSULE; ORALACONENDO LABS/DUPONTALPHA LINELI LILLYDEL-VZ-ADEL-RAY LABSDERM-A-CAPSPHARN ASSOCIATESSOLVISYN ATOWNE PAULSENVI-DOM-A50,000 UNITS50,000 UNITS50,000 UNITS50,000 UNITS/MLEQ 50,000 UNITS BASEEQ 50,000 UHITS BASEEQ 50,000 UNITS BASEEQ 50,000 UNITS BASEEQ 50,000 UNZTS BASEDONE LABS/NILES LABS EQ 50,000 UNITS BASEVITAMIN ACHASE CHEMICALER SQUIBB AND SONSMK LABS .PHARMACAPSPHILIPS ROXANE LABSRICHLYN LABSSTAN LABS PHARNSTERI-MED/KETCHUMWEST-WARDWHARTON LABSZENITH LABSVITAMIN A PALMITATEARCUN PHARMBANNER GELATIN PRODSPHARMACAPSVITAMIN A SOLUBILIZEDLENMON PHARNACALEQ 50,000 UNITS BASEEQ 50,000 UHITS BASEEg 50,000 UNITS BASEEQ 25,000 UNITS BASEEg 50,000 UNITS BASEEg 50,000 UHITS BASEEQ 50,000 UNITS BASEEg 50,000 UNITS BASEEg 50,000 UNITS BASEEg 50,000 UNITS BASEEg 50,000 UNITS BASE- Eg 50,000 UNITS BASEEQ 50,000 UNITS BASEEQ 50,000 UNITS BASEEg 50,000 UNITS BASEEg 50,000 UNITS BASEVITAMIN A PALMITATEINJECTABLE; INJECTIONVITAMIN A PALMITATEBEL-MAR LABSWARFARIN POTASSIUMTABLET; ORALATHROMBIN-KPURDUE FREDERICKWARFARIN SODIUMINJECTABLE; INJECTIONCOUNADINENDO LABS/DUPONTTABLET; ORALATHROMBINBD PURDUE FREDERICKBDBDCOUMADINENDO LABS/DUPONTPANWARFINABBOTT LABSWATER FOR IRRIGATIONEQ 50,000 UNITS BASE2MG * 5MG * 10MG * 25NG50MGIVIAL * 75MG/VIAL5MG * 10MG25MGSOLUTION; IRRIGATIONSTERILE WATERAT TRAVENOL LABS 100ZSTERILE WATER IN PLASTIC COHTAZHERAT ABBOTT LABS 100ZAT AM MCGAW/AM HOSP !QQZAT CUTTER LABS 100ZAT TRAVENOL LABS 100ZWATER. FOR INJECTIONINJECTABLE; INJECTIONSTERILE WATER IN PLASTIC CONTAINERABBOTT LABS 100r.2MG * 2.5MG * 5MG * 7.5MG * lONG2MG * 2.5MG * 5NG * 7.5NG * 10MG
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RXD AND DRUG ACMINISTRATIONAPProVED
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approved application, a list of app
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products that have been approved" i
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To assist the user in relating the
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an evaluatien of therapeutic equiva
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ioavailability data is required for
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B - Drug products that FDA does not
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and the rate of absorption.pharmace
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4. Erythromycin stearate Tablets -
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II. LISTINGSA. FORMAT GUIDEThis p..
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CURRENT STATUS - POSSIBLY EFFECTIVE
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DRUG ProDUCT EKAMPLESSingle Ingredi
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APPROVED PRESCRIPTION DRUG PRODUCTS
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j./APPROVED PRESCRIPTION DRUG PRODU
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-,----APPROVED PRESCRIPTION DRUG PR
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APPROVED PRESCRI~TIOHDRUG PRODUCTSD
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DIMENHYDlHNATEAPPROVED PRESCRIPTION
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------"".,APPROVED PRESCRIPTION DRU
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APPROVED ¥RESCRIPTION DRUG PRODUCT
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'''"APPROVED PRESCRIPTION DRUG PROD
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----..//APPROVED PRESCRIPTION DRUG
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Page 121 and 122: APPROVED PRESCRIPTION DRUG PRODUCTS
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APPROVED PRESCRIPTIOH DRUG PRODUCTS
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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