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

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APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER ABBREVIATION LIST4KEY PHARMSKEY PHARMACEUTICALS INCKIRKMAN LABSKIRKMAN LABORATORIES INCKHOLL PH ARMKNOLL PHARMACEUTICAL COMPANYKREHERS-l1ltMNKREtIERS-URBAN COKV FHAnMACEUTICALKV PHARMACEUTICAL CO** L **LAFAYETTE/ALCOHLAFAYETTE PHARMACAL DIV OF ALCON LABORATORIES INCLAt/NETTTHE LANNETT COMPANY INCLE~ERLF. LABS/AM CYANLEDERLE LABORATORIES DIVISION OF AMERICAN CYANAMID COMPANYLEllERLE PAllEPITE!'?ALSLEDERLE PARENTERALS INCLEIII1PH f'HA~MACALLEMnON PHARMACAL COMPANYLYrJiO-rHmL YPHO-MED INCMALLA~mMALLARD INCM,~LL:r.NCKRrOT** M **MALLINCKRODT INCM;~,!mFACTU!UtIGCHEMMANUFACTURING CHEMISTS INCMN~J:tm LlIEI!.iMARION LABCRATORIES INCMflr.!!'CHALL/tl:r.!.1ES L"~SMARSCHALL DIV MILES LABORATORIES INCMAR!!HAJ..L FHt',l
APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER ABBREVIATION LIST5OWEtf Lt.\BS/ALCl'~1 LABSOWEN LABORATORIES DIV ALCON LABORATORIES** P **P A Hl? A Y IOR~!~HT D ~tlGPANRAY CORPORATION SUB ORMONT DRUG AND CHEMICAL CO INCPAt! f'1~~P.MPAR PHARMACEUTICAL INCP~,"KE-OAVlS LAF);;/['l-LWARt1ER-LAMSERT COMPANY, PARKE-DAVIS LABSPf\~,(E-!JAVZS:/(~-LWARNER-LAMBERT COMPANY~PARK-DAVIS'DIVISIONI'A5f:!J"IlA F("5EM~r,!fPASADENA RESEARCH LABORATORIES INCPt\!.lL B ELDERPAUL B ELDER COPEW'!:ALTPENNt·IALT CORPORATION PHARMACEUTICAL DIVISIONPFAH5T!'OflL LABSPFANSTIEHL LABORATORIES INCpF:I;'[~MmEC'"/PF:l:ZE~PFIPHARtlECS DIVISION PFIZER INCPFrlr::~ LM3SPFIZER LABORATORIES DIV PFIZER INCFtiMm t',~SlC~!ATF.SFHARI1ACEUTICALS ASSOCIATES INC DIV BEACH PRODUCTSPliM
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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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"~''''''-- .APPROVED PRESCRIPTION D
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Page 189 and 190: PERCORTEN PIVALATE, DESOXYCORTICOST
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Page 246 and 247: PRESCRIPTION DRUG PRODUCTS DEEMED A
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