Products: listing products PDB 50 L $1,250.00 5% CO2 IN AIR HIGH LEVEL CALIBRANT GAS AT 15.5 DELTA UNITS ABOVE BASELINE CALIBRANT GAS 10 L $330.00 5% CO2 IN AIR HIGH LEVEL CALIBRANT GAS AT 15.5 DELTA UNITS ABOVE BASELINE CALIBRANT GAS 50 L $1,250.00 5% CO2 IN AIR MIDLEVEL CALIBRANT GAS AT 9.58 DELTA UNITS ABOVE BASELINE CALIBRANT GAS 10 L $330.00 5% CO2 IN AIR MIDLEVEL CALIBRANT GAS AT 9.58 DELTA UNITS ABOVE...
Products: listing products PDB 50 L $1,250.00 5% CO2 IN AIR HIGH LEVEL CALIBRANT GAS AT 15.5 DELTA UNITS ABOVE BASELINE CALIBRANT GAS 10 L $330.00 5% CO2 IN AIR HIGH LEVEL CALIBRANT GAS AT 15.5 DELTA UNITS ABOVE BASELINE CALIBRANT GAS 50 L $1,250.00 5% CO2 IN AIR MIDLEVEL CALIBRANT GAS AT 9.58 DELTA UNITS ABOVE BASELINE CALIBRANT GAS 10 L $330.00 5% CO2 IN AIR MIDLEVEL CALIBRANT GAS AT 9.58 DELTA UNITS ABOVE...
http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 6905 30-Mar-87 ZENECA PHARMACEUTICALS ATENOLOL AS MFG IN GERMANY 6908 07-Apr-87 HONEYWELL IROPHARM PLC DOXYLAMINE SUCCINATE USP 6914 09-Apr-87 FINE CHEMICALS CORP LTD BENZTROPINE MESYLATE AS MFG
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls Arthur Shaw CDER User $ ($) $ ($) $ ($) $ ($) $ $ () $ - () - $ $ () $ - () - -- -- $ ($) $ ($) $ ($) $ ($) / / // -- - - : : :: : () () () () () - $ $ () $ - () - $ $ () $ - : :: : 4Q2003 TYPE2ACTIVEEXCEL DMF # SUBMIT DATE HOLDER SUBJECT CENTRAL SOYA SOYBEAN STEROL PRODUCTS INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE ...
1997 Abbreviated New Drug Applications (Generic Drugs) Generic Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
FDA Drug Approvals List May 2001 Pylori eradication to reduce the risk of duodenal ulcer recurrence, maintenance of healed duodenal ulcers, short-term treatment of active benign gastric ulcer, short-term treatment of symptomatic gastroesophageal reflux disease (GERD), short-term treatment of erosive esophagitis, maintenance of healing of erosive esophagitis, and pathological hypersecretory conditions including...
Prescription and OTC Drug Product List 8/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -A- AA ABLE 300MG;30MG N40452 001 AUG 01, 2002 AUG NEWA -A- AA 300MG;60MG N40459 001 AUG 01, 2002 AUG NEWA ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE TABLET; ORAL ACETAMINOPHEN AND PENTAZOCINE HCL -A- AB AMIDE PHARM 650MG;EQ 25MG BASE N76202 001 AUG...
Prescription and OTC Drug Product List 5/2002 2 -D- + ROBINS AH 325MG;15MG N84444 001 MAY DISC -A- @ 325MG;15MG N84444 001 MAY DISC SOLUTION; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -D- AA ALPHARMA 120MG/5ML;12MG/5ML N85861 001 MAY CRLD -A- AA + 120MG/5ML;12MG/5ML N85861 001 MAY CRLD TYLENOL W/ CODEINE -D- AA + JOHNSON RW 120MG/5ML;12MG/5ML N85057 001 MAY DISC -A- @ 120MG/5ML;12MG/5ML N85057 001 MAY DISC TABLET; ORAL...
http://www.merck.com/product/usa/pi_circulars/c/cogentin/cogentin_pi.pdf 7924125 1 INJECTION COGENTIN ® (BENZTROPINE MESYLATE) DESCRIPTION Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine
duplicates:http://www.merck.com/product/usa/pi_circulars/c/cogentin/cogentin_pi.pdf
http://www.merck.com/product/usa/pi_circulars/c/cogentin/cogentin_pi.pdf page 4
duplicates:http://www.merck.com/product/usa/pi_circulars/c/cogentin/cogentin_pi.pdf
http://www.merck.com/product/usa/pi_circulars/c/cogentin/cogentin_pi.pdf page 3
duplicates:http://www.merck.com/product/usa/pi_circulars/c/cogentin/cogentin_pi.pdf
http://www.merck.com/product/usa/pi_circulars/c/cogentin/cogentin_pi.pdf page 2
duplicates:http://www.merck.com/product/usa/pi_circulars/c/cogentin/cogentin_pi.pdf
http://www.merck.com/product/usa/pi_circulars/c/cogentin/cogentin_pi.pdf page 1
duplicates:http://www.merck.com/product/usa/pi_circulars/c/cogentin/cogentin_pi.pdf
http://www.fda.gov/cder/foi/label/2001/18821s20lbl.pdf Reglan ® Tablets (Metocloprami e Tablets, USP) Reglan ® S rup (Metocloprami e Oral Solution, USP) Reglan ® Injectable (Metocloprami e Injection, USP) CI 601 only DESCRIPTION For oral a ministration, Reglan Tablets ( Metocloprami e Tablets, USP) 10 mg are white, score , capsule- shape engrave on one si e an 10 on the opposite si e
http://www.fda.gov/cder/foi/label/2001/18821s20lbl.pdf page 2
http://www.fda.gov/cder/foi/label/2001/12015s23lbl.pdf 7924121 TABLETS AND INJECTION COGENTIN ® (BENZTROPINE MESYLATE) DESCRIPTION Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramineBenztropine mesylate is a crystalline white powder, very soluble in water, and...
http://www.fda.gov/cder/foi/label/2001/12015s23lbl.pdf page 4
http://www.fda.gov/cder/foi/label/2001/12015s23lbl.pdf page 3
http://www.fda.gov/cder/foi/label/2001/12015s23lbl.pdf page 2
http://www.fda.gov/cder/foi/label/2001/12015s23lbl.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 at 56- 57oC) 3.00 mL Antirabies Serum 3.00 mL Antitoxin (Gas Gangrene) 3.00 mL Antivenom 3.00 mL Apommorphine HCl Tablets for Injection 0.09 mg Arginine HCl Injection 500.00 mg Ascorbic Acid 4.20 mg Asparaginase for Injection 1000.00 Iu Atracurium Besylate 0.50 mg Atropine Sulfate 0.09 mg Aurothioglucose Suspension 0.70 mg Azathioprine Sodium for Injection 5.00 mg Azlocillin 75.00 mg...
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 2
author: FDA / CBER
subject: December 1987 Guideline
Drug Approvals December 1996 Drug Approvals for December 1996 Definitions and Notes December 1996 Original New Drug Applications Original Application #: 020681 Approval Date: 31-DEC-96 Trade Name: ORTHO TRI-CYCLEN Chemical Type: 6 Therapeutic Potential: S Dosage Form: TABLET Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP Active Ingredient(s): ETHINYL ESTRADIOL; NORGESTIMATE...
Drug Approvals September 1996 CATARRHALIS TO THE INDICATIONS AND USAGE SECTION Approvable Original New Drug Applications Original Application #: 020535 Approvable Date: 30-SEP-96 Trade Name: DURACT Dosage Form: CAPSULE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): BROMFENAC SODIUM OTC/RX Status: RX Original Application #: 020690 Approvable Date: 19-SEP-96 Trade Name: ARICEPT Dosage Form: TABLET...
