Merck - Products/USA - A
The left navigation bar requires Javascript to be enabled. Please enable Javascript on your browser or use the Site Map to navigate. - Prescribing Information for Merck Products For Healthcare Professionals in the United States A- // The product information presented here is intended for use in the United States only. Other countries may have different regulatory...
http://www.merck.com/product/usa/pi_circulars/a/aminohippurate/aminohippurate_sodium_pi.pdf
9051024 INJECTION AMINOHIPPURATE SODIUM * "PAH" DESCRIPTION Aminohippurate sodium is an agent to measure effective renal plasma flow (ERPF). Each 10 mL contains: Aminohippurate sodium 2 g. Inactive ingredients: Sodium hydroxide to adjust pH, water for injection, q. It is ideally suited for measurement of ERPF since it has a high clearance, is essentially...
http://www.merck.com/product/usa/pi_circulars/a/aminohippurate/aminohippurate_sodium_pi.pdf page 3
http://www.merck.com/product/usa/pi_circulars/a/aminohippurate/aminohippurate_sodium_pi.pdf page 1
Drug Approvals - A
This newly approved or tentatively approved drug listing is an interim page intended to provide timely information on new drug products as a more comprehensive page is developed NDA 18-662/S-038 5/1/00 1/17/01 - - Acebutolol Hydrochloride Capsules,200 mg (base) and 400 mg (base) Chelsea Laboratories, Inc Expanded indication: Agrylin Capsules are indicated for the treatment...
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,...
Merck - Products/USA - A
sb_genLeftNav(); - Prescribing Information for Merck Products For Healthcare Professionals in the United States The product information presented here is intended for use in the United States only Select by product name: // AGGRASTATA® (tirofiban HCI) A- Full Prescribing Information ALDOMETA® (methyldopa) Tablets A- Full Prescribing Information ALDORILA® (methyldopa...
http://www.merck.com/product/usa/pi_circulars/a/aminohippurate/aminohippurate_sodium_pi.pdf
9051023 INJECTION AMINOHIPPURATE SODIUM * "PAH" DESCRIPTION Aminohippurate sodium is an agent to measure effective renal plasma flow (ERPF) Each 10 mL contains: Aminohippurate sodium 2 g Inactive ingredients: Sodium hydroxide to adjust pH, water for injection, q PAH is also used to measure the functional capacity of the renal tubular secretory mechanism or...
http://www.merck.com/product/usa/pi_circulars/a/aminohippurate/aminohippurate_sodium_pi.pdf page 3
http://www.merck.com/product/usa/pi_circulars/a/aminohippurate/aminohippurate_sodium_pi.pdf page 1
RLD_LABELING_APPROVED_NOV_1999
Firm Date AMINOHIPPURATE Na Na Aminohippurate 5-619 S-015 Merck 2-Nov-1999 FLOLAN Epoprostenol Na Injection 20-444 S-004 Glaxo Wellcome 2-Nov-1999 DEXEDRINE Dextroamphetamine SO4 ER Capsules 17-078 S-034 SmithKline Beecham 3-Nov-1999 ZOLADEX Goserelin Acetate Implant 20-578 S-009 Zeneca 3-Nov-1999 ZOLADEX Goserelin Acetate Implant 3.6 Mg 19-726 S-030 Zeneca 3-Nov-1999...
C:\Data\WPFILES\N561916a.doc page 1
author: Stephen McCort
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
APPENDIX E MAXIMUM DOSE AND ENDOTOXIN LIMIT TABLE April ,1992 Drug Name Acetic Acid Irrigation Acetazolamide Sodium Acetylcysteine Injection Acyclovir Sodium Adenosine Phosphate Albumin, Normal Human Serum (25%) Albumin, Normal Human Serum (20%) Albumin, Normal Human Serum (5%) Albuterol Sulfate Alcohol and Dextrose Injection Alfentanil Hydrochloride Alkaloids of Belladonna Alpha,-...
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 1
author: FDA / CBER
subject: December 1987 Guideline
C:\Data\WPFILES\N561916a.doc page 1
author: Stephen McCort
FDA Drug Approvals List November 1999
Approvable Original New Drug Applications Original Application #: 020125 Approvable Date: 30-NOV-99 Trade Name: ACCURETIC Dosage Form: TABLET Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO Active Ingredient(s): QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE OTC/RX Status: RX Original Abbreviated Application #: 075366 Tentative Approval Date: 02-NOV-99 Trade Name:...