http://www.fda.gov/cder/orange/appendix_a.txt PEDIATRIC, ASCORBIC ACID M.V.I.-12 LYOPHILIZED, ASCORBIC ACID M.V.I.-12, ASCORBIC ACID MACROBID, NITROFURANTOIN MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE MACROTEC, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT MAGNACORT, HYDROCORTAMATE HYDROCHLORIDE MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE...
Prescription and OTC Drug Product List 6/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA PEACHTREE 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN -A- AA UCB 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL DARVOCET -A- @ AAIPHARMA LLC 325MG;32.5MG N16844 001 JUN CAHN -D- @...
Prescription and OTC Drug Product List 8/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 8: August 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AZATHIOPRINE SODIUM CAPSULE; ORAL INJECTABLE; INJECTION FEMCET IMURAN - DLT - AB MALLINCKRODT 325MG;50MG;40MG N89102 001 - ADD - AP + FARO PHARMS EQ 100MG BASE...
Reformulation and Stability testing of an Ergotamine Tartrate MD1 based onHydrofluoroalkanes 3M's Medihaler Ergotamine with a label dose of 360 µg of drug per spray and a total of 75 doses was reformulated using HFAs
http://www.fda.gov/cder/da/ddpa94.wpd 18 473 VENTOLIN GLAXO ALBUTEROL 02 FEB 94 (AEROSOL, METERED) RES TRIANGLE PK, NC 0.09MG/INH 27709 (LABELING REVISION PRECAUTIONS; PATIENT'S INSTRUCTIONS FOR USE) 19 548 TORNALATE STERLING WINTHROP BITOLTEROL MESYLATE 02 FEB 94 (SOLUTION) MALVERN, PA 0.2% 19355 (LABELING REVISION WARNINGS; OVERDOSAGE; DOSAGE AND ADMINISTRATION; PRECAUTIONS) 16 659 NORINYL 1+50 28 DAY SYNTEX (FP)...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt ERGOTAMINE TARTRATE 3039 10-Oct-77 LOFTUS BRYAN CHEMICALS LTD PROMETHAZINE HCL 3048 25-Oct-77 DINAMITE DIPHARMA SPA d-PROPOXYPHENE NAPSYLATE 3052 18-Oct-77 DINAMITE DIPHARMA SPA SPIRONOLACTONE 3053 17-Nov-77 PHARMACIA AND UPJOHN INC "TESTOLACTONE, USP" 3061 14-Nov-77 DANISCO INGREDIENTS VALPROIC ACID 3062 09-Nov-77 PCR INC "5-FLUOROURACIL AS MANUF IN HUMACAO, PUERTO RICO"...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls NAPROXEN SCHERING AG NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) PHARMACIA AND UPJOHN INC TRIAMCINOLONE PFANSTIEHL LABORATORIES INC CREATINE PALL CORP FILTER CARTRIDGE PHARMACIA AND UPJOHN SPA ADRIAMYCIN HCL BULK LUNDBECK PHARMACEUTICALS ITALY SPA HYDROCHLOROTHIAZIDE USP SOLMAG S.P.A PHENDIMETRAZINE TARTRATE SIFAVITOR SPA TRICHLORMETHIAZIDE NF XIII LILLY RES LABS DIV ELI...
Prescription and Over-the-Counter Drug Product List: 3/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG N40441 001...
author: AUTHOR
FDA Drug Approvals List June 2002 - Drug Approvals for June 2002 Definitions and Notes Original New Drug Applications Original Application # 021316 Approval Date: 26-JUN-02 Trade Name: ALTOCOR Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: AURA LABORATORIES INC Active Ingredient(s): LOVASTATIN OTC/RX Status: RX INDICATION OF USE: For lowering total cholesterol and LDL-C to target levels as...
http://www.analis.be/files/applications/CEofixAnionsPharma.pdf Figure 6 : Counter- ions of different drugs : (A) Ipramine bromide, (B) Mephenterium sulphate, (C) Ergotamine tartrate, (D) Pentoxyverin citrate, (E) Dimethinden maleate at 100µg/ mL, analysed with P/ ACE MDQ, CEofixª Anions5 and fused silica capillary : 75µ x 60 cmTartrate, (4) Citrate, (5) Maleate
http://www.analis.be/files/applications/CEofixAnionsPharma.pdf page 7
http://www.analis.be/files/applications/CEofixAnionsPharma.pdf page 1
Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices Conc.( equine) 3.00 mL Dipyridamole 0.14 mg Dobutamine HCI 0.90 mg 5.00 1.10 2.17 3.57 1.80 1.80 1.80 1.80 45.45 5.00 1.25 5.56 11.60 + 0.50 + 35.70 + 71.43 16.70 + 17.20 + 0.70 + 0.70 + 111.00 + 200.00 + 1.00 357.00 0.003 + 0.50 + 166.67 1.00 4.00 0.50 + 1.00 8.77 3.40 + 16.67 1.67 37.70 5.56 40 Dopamine HCI Dopamine HCl in Dextrose Doxapram HCI Injection Doxorubicin HCI for...
author: FDA / CBER
subject: December 1987 Guideline
Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices page 7
author: FDA / CBER
subject: December 1987 Guideline
Sheffield Pharmaceuticals Sheffield Home Page Delivery Technologies Terms and Conditions - Scientific Presentations Presentation -#1 Pulmonary delivery of ergotamine tartrate using a new breath-actuated pressurized aerosol device, the Tempo TM Inhaler (Tempo) Presentation #2 Deposition, absorption and bioavailability of aerosolized morphine sulfate delivered by a novel hand-held device, the Premaire TM...
FDA Drug Approvals List October 2000 - Drug Approvals for October 2000 Definitions and Notes Original New Drug Applications Original Application #: 020958 Approval Date: 16-OCT-00 Trade Name: PEPCID COMPLETE Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET, CHEWABLE Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC Active Ingredient(s): CALCIUM CARBONATE, PRECIPITATED; FAMOTIDINE; MAGNESIUM HYDROXIDE...
Reformulation and Stability testing of an Ergotamine Tartrate MD1 based onHydrofluoroalkanes Reformulation and Stability testing of an Ergotamine Tartrate MDI based on Hydrofluoroalkanes (HFAs) using a Bespak Actuator and a- novel aerosol drug delivery system (ADDS) CHARTED TEST RESULTS Figure 2: Comparison of the Particle Size Distribution (Andersen Cascade Impaction) of the ET pMDI using a Bespak Actuator and the ADDS Figure 3: Particle Size Distribution of...
