http://www.fda.gov/cder/orange/appendix_a.txt ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
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 ...
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)...
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...
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...
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 8/1999 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,...
Microsoft Word - Supp 025 AP letter.doc C- 671- LB01 C- 671- LB01 CARTON HAS BEEN OPENED IMPORTANTN SEE WARNINGS ON ACCOMPANYING CIRCULAR KEEP IN A COLD PLACE AVOID FREEZING ExpLENTE ® ILETIN ® II NDC 0002- 8411- 01 NDC 0002- 8411- 01 10 mL CP- 410P 100 UNITS PER mL LENTE ® ILETIN ® II INSULIN ZINC SUSPENSION, USP PURIFIED PORK SF 5533 AMS SF 5533 AMS SF 5533 AMS...
author: RHEEJ
1997 New Drug Application (NDA) 050757 12/2/1997 2/6/1998 Lente Purified Pork Insulin Zinc Suspension USP [1 MB] Novo Nordisk Pharmaceuticals, IncInsulin (rDNA origin) [1 MB] Novo Nordisk Pharmaceuticals, IncInsulin (rDNA origin) [1 MB] Novo Nordisk Pharmaceuticals, Inc...
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...
Microsoft Word - Supp 025 AP letter.doc page 1
author: RHEEJ
Supp 041 AP letter.doc Humalog 14 injection consists of zinc - insulin lispro crystals dissolved in a clear aqueous fluidinsulin lispro 100 Units, 16 mg glycerin, 1.88 mg 16 dibasic sodium phosphate, 3.15 mg m- cresol, zinc oxide content adjusted to provide 0.0197 mg 17 zinc ion, trace amounts of phenol, and water for...
author: RHEEJ
DOCUMENT INFORMATION PAGE 1 PA 6603 AMP INFORMATION FOR THE PATIENT VIAL HUMALOG® INSULIN LISPRO INJECTION (rDNA ORIGIN) 100 Units per mL (U- 100) WARNINGS THIS LILLY HUMAN INSULIN ANALOG IS DIFFERENT FROM OTHER INSULINS BECAUSE IT HAS A RA ONSET AND SHORTER DURATION OF ACTIONLENTE), SPECIES (BEEF, PORK, BEEF- PORK, HUMAN), OR METHOD OF...
author: JR, CDER
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
Chapter 1 17 TABLE 4.3 Insulin Preparations Available in Canada * Manufacturer Insulin Vial/ Cartridge Size Available ELI LILLY CANADA Insulin Analogue Humalog (lispro) 10 ml vial/3.0 ml cartridge Humalog® Mix 25 (25% Humalog, 75% NPL) 3.0 ml cartridge Human Insulin Humulin R (regular,Toronto) 10 ml vial Humulin N (NPH) Humulin L (lente) Humulin U (ultralente)...
author: BBDC
Chapter 1 page 17
author: BBDC
http://www.bbdc.org/pdf/Chapter4.pdf 17 TABLE 4.3 Insulin Preparations Available in Canada * Manufacturer Insulin Vial/ Cartridge Size Available ELI LILLY CANADA Insulin Analogue Humalog (lispro) 10 ml vial/ 3.0 ml cartridge Humalog® Mix 25 (25% Humalog, 75% NPL) 3.0 ml cartridge Human Insulin Humulin R (regular, Toronto) 10 ml vial Humulin N (NPH) Humulin L (lente) Humulin U (ultralente)...
author: Rose LaBarbera
http://www.bbdc.org/pdf/Chapter4.pdf page 6
author: Rose LaBarbera
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/foi/label/2001/19991s37lbl.pdf NDA 19- 991/ S- 037 (document submission date 8/ 14/ 01) FDA revision date 8/ 21/ 01 Page 1 Novo Nordisk Insulin Information For The Patient Using Novolin® 70/ 30 FlexPenO O 70% NPH, Human Insulin Isophane (recombinant DNA origin) Suspension & and 30% Regular, Human Insulin (recombinant DNA origin) Injection (recombinant DNA origin) in a 3 mL disposable...
http://www.fda.gov/cder/foi/label/2001/19991s31lbl.pdf NDA 19- 991/ S- 031 (6/ 29/ 01 submission) FDA revision date 8/ 23/ 01 Page 1 Novo Nordisk® Insulin Information For The Patient 3 mL Disposable Insulin Delivery Device Novolin® 70/ 30 InnoLet® Prefilled Syringe NPH, 70% NPH, Human Insulin Isophane (recombinant DNA origin) Suspension and Suspension 30% Regular, human insulin (recombinant DNA...
http://www.fda.gov/cder/foi/label/2001/19959s36lbl.pdf NDA 19- 959/ S- 036 (8/ 14/ 01 submission) FDA revision date: 8/ 22/ 01 Page 1 Novo Nordisk Insulin Information For The Patient Using Novolin® N FlexPenO O NPH, Human Insulin Isophane (recombinant DNA origin) Suspension (recombinant DNA origin) in a 3 mL Prefilled Insulin Syringe 100 units/ mL (U- 100) Please read both sides of this leaflet carefully before...
hut6043.tmp page 17
author: fda
duplicates:http://www.fda.gov/cder/foi/nda/97/018381ap.pdf http://www.fda.gov/cder/foi/nda/97/018623ap.pdf http://www.fda.gov/cder/foi/nda/97/019938ap.pdf http://www.fda.gov/cder/foi/nda/97/019959ap.pdf http://www.fda.gov/cder/foi/nda/97/019965ap.pdf http://www.fda.gov/cder/foi/nda/97/019991ap.pdf http://www.fda.gov/cder/foi/nda/97/018383ap.pdf
hut6043.tmp page 2
author: fda
duplicates:http://www.fda.gov/cder/foi/nda/97/018381ap.pdf http://www.fda.gov/cder/foi/nda/97/018623ap.pdf http://www.fda.gov/cder/foi/nda/97/019938ap.pdf http://www.fda.gov/cder/foi/nda/97/019959ap.pdf http://www.fda.gov/cder/foi/nda/97/019965ap.pdf http://www.fda.gov/cder/foi/nda/97/019991ap.pdf http://www.fda.gov/cder/foi/nda/97/018383ap.pdf
