http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA,...
DDPA February 1995 74-047 ZIDOVUDINE BARR ZIDOVUDINE 24-FEB-95 (C APSULE) POMONA, NY 100MG 10970 (ANTIVIRAL) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-970 NOLVADEX ZENECA PHARMS TAMOXIFEN CITRATE 01-FEB-95 (TABLET) WILMINGTON, DE EQ 10MG BASE 19850 (LABELING REVISION -- WARNINGS) 20-055 GLYBURIDE (MICRONIZED) HOECHST ROUSSEL GLYBURIDE 01-FEB-95 (TABLET) SOMERVILLE, NJ 1.5MG 08876 3MG (LABELING...
http://www.fda.gov/cder/da/ddpa93.wpd 03 158 ORETON METHYL SCHERING METHYLTESTOSTERONE 01 07 93 (TABLET) KENILWORTH, NJ 10MG 07033 (REVISED LABELING PRECAUTIONS) 50 590 TIMENTIN SMITHKLINE BEECHAM CLAVULANATE POTASSIUM 01 07 93 (INJECTABLE) PHILADELPHIA, PA EQ 100MG ACID/VIAL 19101 TICARCILLIN DISODIUM EQ 3GM BASE/VIAL (REVISED LABELING PRECAUTIONS) 50 590 TIMENTIN SMITHKLINE BEECHAM CLAVULANATE POTASSIUM 01 07 93 ...
http://www.fda.gov/cder/da/ddpa94.wpd 17 926 INSULIN NOVO NORDISK PHARMS INSULIN PORK 03 JAN 94 (INJECTABLE) PRINCETON, NJ 100 UNITS/ML 08540 (LABELING REVISION SYRINGES; NEEDLE-FREE INJECTORS) (OTC) 17 929 NPH INSULIN NOVO NORDISK PHARMS INSULIN SUSP ISOPHANE BEEF 03 JAN 94 (INJECTABLE) PRINCETON, NJ 100 UNITS/ML 08540 (LABELING REVISION SYRINGES; NEEDLE-FREE INJECTORS) (OTC) 17 996...
Prescription and OTC Drug Product List 8/1999 RTU IN PLASTIC CONTAINER - DLT - MAR 19, 1999 - ADD - AP + BAXTER HLTHCARE 500MG/100ML N18657 001 - DLT - AP + SCS 500MG/100ML N18657 001 LORACARBEF MINOCYCLINE HYDROCHLORIDE CAPSULE; ORAL LORABID CAPSULE; ORAL - ADD - KING PHARMS 200MG N50668 001 - DLT - MINOCYCLINE HCL - ADD - DEC 31, 1991 - DLT - AB WARNER CHILCOTT EQ 50MG BASE N63066 001 - ADD - + 400MG N50668 002 - DLT - AUG 14,...
http://www.fda.gov/cder/da/ddpa92.wpd 50 671 VANCOCIN HCL LILLY VANCOMYCIN HYDROCHLORIDE 03 24 92 IN PLASTIC CONTAINER INDIANAPOLIS, IN EQ 500MG BASE/100ML (INJECTABLE) 46285 (ANTIBIOTIC, GLYCOPEPTIDE) 19 830 LIDOCAINE HCL MCGAW LIDOCAINE HYDROCHLORIDE 03 26 92 IN DEXTROSE 5% IN IRVINE, CA 200MG/100ML PLASTIC CONTAINER 92713 400MG/100ML (INJECTABLE) 800MG/100ML (ANTIARRHYTHMIC) 19 881 BUTOCONAZOLE NITRATE SYNTEX...
Prescription and OTC Drug Product List 2/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION; ORAL AUGMENTIN '400' -D- + GLAXOSMITHKLINE 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD -A- 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL ...
Prescription and OTC Drug Product List 5/2001 IRRIGANT NYSTATIN - ADD - MONARCH PHARMS EQ 40MG BASE/ML; - ADD - @ TEVA 100,000 UNITS/GM N61966 001 - ADD - 200,000 UNITS/ML N60707 001 OINTMENT; TOPICAL - DLT - NILSTAT NETILMICIN SULFATE - DLT - AT + LEDERLE 100,000 UNITS/GM N61444 001 - ADD - @ 100,000 UNITS/GM N61444 001 - DLT - INJECTABLE; INJECTION NYSTATIN - DLT - NETROMYCIN - DLT - AT ALTANA 100,000 UNITS/GM N62124 002 - DLT...
Drug Approvals for April 1997 Drug Approvals for April 1997 Definitions and Notes April 1997 Original New Drug Applications Original Application #: 020619 Approval Date: 17-APR-97 Trade Name: BETOPTIC PILO Chemical Type: 4 Therapeutic Potential: S Dosage Form: SUSPENSION/DROPS Applicant: ALCON LABORATORIES INC Active Ingredient(s): BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE OTC/RX Status: RX Indication(s)...
DOCUMENT INFORMATION PAGE NDA 18- 780/ S- 067 & S- 078 Approved draft (2/ 7/ 03) Page 1 Lilly's submission date: 1/ 28/ 03 NL 4460 AMP INFORMATION FOR THE PATIENT HUMULIN ® R REGULAR INSULIN HUMAN INJECTION, USP, (rDNA ORIGIN) WARNINGS THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM ANIMAL- SOURCE INSULINS BECAUSE IT IS STRUCTURALLY IDENTICAL TO THE INSULIN PRODUCED BY YOUR BODY'S...
author: JR, CDER
Prescription and Over-the-Counter Drug Product List: 12/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> + MIKART 750MG;50MG;40MG N40496 001 DEC 23, 2003 DEC NEWA ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE TABLET; ORAL DARVOCET A500 >D> + AAIPHARMA 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA >A> + 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA...
FDA DRUG AND DEVICE PRODUCT APPROVALS 74-776 TIMOLOL MALEATE BAUSCH AND LOMB TIMOLOL MALEATE 26-JUL-96 (SOLUTION/DROPS) TAMPA, FL 0.5% 33637 (BETA ADRENERGIC BLOCKER) 74-778 TIMOLOL MALEATE BAUSCH AND LOMB TIMOLOL MALEATE 26-JUL-96 (SOLUTION/DROPS) TAMPA, FL 0.25% 33637 (BETA ADRENERGIC BLOCKER) 74-465 TIMOLOL MALEATE ADV REMEDIES TIMOLOL MALEATE 30-JUL-96 (SOLUTION/DROPS) SOMERSET, NJ 0.25% 08873 (BETA ADRENERGIC...
FDA Drug Approvals List March 2002 ROBBINS Active Ingredient(s): GUANFACINE HYDROCHLORIDE OTC/RX Status: RX Application #: 019991 Labeling Supplement #: 032 To Original New Drug Application Approval Date: 11-MAR-02 Trade Name: NOVOLIN 70/30 Dosage Form: INJECTABLE Applicant: NOVO NORDISK PHARMACEUTICALS INC Active Ingredient(s): INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHAN E RECOMBINANT HUMAN OTC...
FDA Drug Approvals List February 2002 Active Ingredient(s): BUSPIRONE HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application#065022 Approval Date: 27-FEB-02 Trade Name: BACITRACIN ZINC AND POLYMYXIN B SULFATE Dosage Form: OINTMENT Applicant: ALTANA INC Active Ingredient(s): BACITRACIN ZINC; POLYMYXIN B SULFATE OTC/RX Status: RX Original Abbreviated Application# 075874 Approval Date: 26...
Prescription and OTC Drug Product List 8/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 8: August 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL - ADD - BUTALBITAL, ACETAMINOPHEN AND CAFFEINE MODURETIC 5-50 - ADD - AB MALLINCKRODT...
