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 Drug Product List 1/96 PRESCRIPTION DRUG PRODUCT LIST 16TH EDITION RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / JAN'96 ACETAMINOPHEN; CODEINE PHOSPHATE CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE TABLET; ORAL - ADD - ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION; INTRAPERITONEAL - ADD - AA MIKART 300MG;60MG N89244 001 - ADD - DELFLEX W/ DEXTROSE 4.25% IN...
FDA Drug Approvals List- January 1998 Drug Approvals for January 1998 Definitions and Notes January 1998 Original New Drug Applications Original Application #: 050731 Approval Date: 30-JAN-98 Trade Name: DAUNORUBICIN HCL Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC Active Ingredient(s): DAUNORUBICIN HYDROCHLORIDE OTC/RX Status: RX...
FDA Drug Approvals List- January 1999 Drug Approvals for January 1999 Definitions and Notes January 1999 Original New Drug Applications Original Application #: 020781 Approval Date: 27-JAN-99 Trade Name: ZOFRAN ODT Chemical Type: Therapeutic Potential: Dosage Form: TABLET Applicant: GLAXO WELLCOME INC Active Ingredient(s): ONDANSETRON OTC/RX Status: RX Indication(s): For the prevention of chemotherapy and radiation...
DDPA January 1996 Drug and Device Product Approvals for January 1996 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 19-963 RENOVA RW JOHNSON TRETINOIN 29-DEC-95 (CREAM) RARITAN, NJ 0.05% (3 S) 08869 (RETINOID) 20-353 NAPRELAN ELAN NAPROXEN SODIUM 05-JAN-96 (TABLET, GAINESVILLE, GA EQ 375MG BASE (3 S) EXTENDED RELEASE) 30504 EQ 500MG BASE EQ 750MG BASE (NONSTEROIDAL ANTI-INFLAMMATORY) 20...
FACT SHEET TABLE 3 Average Concentrations of Cefepime in Specific Body Fluids (µg/ mL) or Tissues (µg/ g) Rx only HCI ° H2N H2O OCH3 CH3 N N N H H H N N S S O O COOH Cl MAXIPIME Parameter 500 mg IV 1 g IV 2 g IV 0.5 h 38.2 78.7 163.1 1.0 h 21.6 44.5 85.8 2.0 h 11.6 24.3 44.8 4.0 h 5.0 10.5 19.2 8.0 h 1.4 2.4 3.9 12.0 h 0.2 0.6 1.1 Cmax' µg/ mL 39.1 (3.5) 81.7 (5...
author: K. Notarianni
MAX0173 Full PI-4 pager TABLE 3 Average Concentrations of Cefepime in Specific Body Fluids (µg/ mL) or Tissues (µg/ g) Rx only HCI ° H2N H2O OCH3 CH3 N N N H H H N N S S O O COOH Cl MAXIPIME Parameter 500 mg IV 1 g IV 2 g IV 0.5 h 38.2 78.7 163.1 1.0 h 21.6 44.5 85.8 2.0 h 11.6 24.3 44.8 4.0 h 5.0 10.5 19.2 8.0 h 1.4 2.4 3.9 12.0 h 0.2 0.6 1.1 Cmax' µg/ mL 39.1 (3.5) 81.7 (5...
author: Freelance
V:\DAIDP\PEAT\Approval Letter\N50679SE2.doc NDA 50- 679/ S- 021 Page 3 Rx only 03/ 13/ 03 MAXIPIME ® (Cefepime Hydrochloride) for Injection For Intravenous or Intramuscular Use DESCRIPTION Cefepime hydrochloride is a semi- synthetic, broad spectrum, cephalosporin antibiotic for parenteral administrationMAXIPIME (CEFEPIME HYDROCHLORIDE) FOR...
author: Raquel Peat
FACT SHEET page 5
author: K. Notarianni
duplicates:http://www.elan.com/Images/Maxipime_PI_200204_tcm3-4348.pdf
http://www.fda.gov/cder/ogd/rld/50679s13.PDF page 5
Drug Approvals - M NDA 13-422/S-035 4/17/03 - - - Maxipime (Cefepime Hydrochloride) Injection,-Rx Bristol-Myers Squibb NDA 50-679/S-21 3/17/03 3/26/03 3/26/03 Maxipime (Cefepime Hydrochloride) Injection,- Bristol-Myers Squibb NDA 50-679/S-009, S-014 and S-018 8/21/02 8/26/02 - Maxipime (Cefepime Hydrochloride) Injection Bristol-Myers Squibb NDA 50...
FACT SHEET page 6
author: K. Notarianni
duplicates:http://www.elan.com/Images/Maxipime_PI_200204_tcm3-4348.pdf
FACT SHEET page 4
author: K. Notarianni
duplicates:http://www.elan.com/Images/Maxipime_PI_200204_tcm3-4348.pdf
FACT SHEET page 3
author: K. Notarianni
duplicates:http://www.elan.com/Images/Maxipime_PI_200204_tcm3-4348.pdf
50679S007_Maxipine.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Maxipime (Cefepime Hydrochloride) Injection Company:- Bristol-Myers Squibb Application No.:- 50-679/S007 Approval Date:-1/27/1999 - Approval Letter(s) - Printed Labeling - Medical Review(s) - Administrative Document(s) - - Back to Drug Approval Page Some documents are...
author: Paul Stauffer
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_JAN_1999.HTML 20-869 001 Merck Res 4-Jan-1999 LESCOL Fluvastatin Sodium Capsule 20-261 019 Novartis Pharm 4-Jan-1999 CORDARONE Amiodarone Hydrochloride Tablets 200 mg 18-972 017 Wyeth Ayerst Labs 5-Jan-1999 LAMISIL Terbinafine HCl Tablets 20-539 003 Novartis Pharms 5-Jan-1999 LOESTRIN FE 1.5/30 Ethinyl Estradiol/Norethindrone Tablets 17-355 043 Parke Davis 8-Jan-1999 LOESTRIN FE 1/20 Ethinyl...
050679S002 Maxipime (Cefepime Hydrochloride) for Injection Maxipime (Cefepime Hydrochloride) for Injection Company:- Bristol-Myers Squibb Application No.:- 50-679/S-002 Approval Date:-5/16/1997 - Approval Letter (318 KB) Medical Review(s) Part 1 (2.6 MB) Part 4 (2.9 MB) Part 7 (2 MB) Part 2 (2.6 MB) Part 5 (2.8 MB) - Part 3 (2.8 MB) Part 6 (2.9 MB) - Statistical Review(s) & Administrative Document(s) - (103 KB) Back to Drug...
author: CDERUSERNAME
V:\DAIDP\PEAT\Approval Letter\N50679SE2.doc page 22
author: Raquel Peat
V:\DAIDP\PEAT\Approval Letter\N50679SE2.doc page 12
author: Raquel Peat
V:\DAIDP\PEAT\Approval Letter\N50679SE2.doc page 1
author: Raquel Peat
Drug Approvals for May 1997 orbiculare) Application #:020297Efficacy Supplement#:001 Type: SE1 to Original New Drug Application Approval Date: 29-MAY-97 Trade Name: COREG Dosage Form: TABLET Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): CARVEDILOL OTC/RX Status: RX Efficacy Claim: For the new indication of congestive heart failure and a new dosage strength of 3.125 mg Application #...
FDA Drug Approvals List- February 1999 Applicant: CONNETICS CORP Active Ingredient(s): BETAMETHASONE VALERATE OTC/RX Status: RX Indication(s):For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp Original Application #: 020969 Approval Date: 25-FEB-99 Trade Name: UVADEX Chemical Type: 3 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: THERAKOS INC...
FDA Drug Approvals List September 2000 PEDIATRIC Dosage Form: INJECTABLE Applicant: ASTRAZENECA LP Active Ingredient(s): ASCORBIC ACID; VITAMIN A; ERGOCALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; DEXPANTHENOL; VITAMIN E; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; PHYTONADIONE; NIACINAMIDE OTC/RX Status: RX Application #: 050679 Labeling Supplement#: 013 To Original New...
http://www.fda.gov/cder/ogd/rld/50679s13.PDF page 6
http://www.fda.gov/cder/ogd/rld/50679s13.PDF page 4
