Drug Approvals - O Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Ocufen Ophthalmic Solution, (0.03%) Allergan NDA 19-404/S020 8/25/03 8/28/03 8/28/03 - Ocufen Ophthalmic Solution (0.03%) Allergan NDA 19-404/S017 8/17/01 - 4/15/03 - Ocufen Ophthalmic Solution (0.03%) Allergan NDA 19-404/S014 7/30/01 - 4/15/03 - Ofloxacin Injection, 40 mg/mL packaged in 10 mL...
http://www.fda.gov/cder/orange/appendix_a.txt IRRIGANT, NEOMYCIN SULFATE NEOSPORIN, BACITRACIN ZINC NEOSPORIN, GRAMICIDIN NEOSPORIN, NEOMYCIN SULFATE (OTC) NEOTHYLLINE, DYPHYLLINE NEOTRIZINE, TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE; SULFAMETHAZINE) NEPHRAMINE 5.4%, AMINO ACIDS NEPHROFLOW, IODOHIPPURATE SODIUM, I-123 NEPTAZANE, METHAZOLAMIDE NESACAINE, CHLOROPROCAINE HYDROCHLORIDE NESACAINE-MPF, CHLOROPROCAINE...
75-117_Orapred.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Orapred (Prednisolone Sodium Phosphate) Oral Solution Company:--Ascent Pediatrics Application No.:--75-117 Approval Date:-12/14/2000 - Approval Letter(s) - Printed Labeling Chemistry Review(s) - Bioequivalence Review(s) - Administrative Document(s) - Correspondence - ...
author: Paul Stauffer
Prescription and OTC Drug Product List 6/2002 -A- + GD SEARLE LLC EQ 500MG BASE/VIAL N18353 001 JUL CAHN -D- + SCS EQ 500MG BASE/VIAL N18353 001 JUL CAHN MIDAZOLAM HYDROCHLORIDE INJECTABLE; INJECTION MIDAZOLAM HCL -A- AP ABBOTT EQ 1MG BASE/ML N75857 001 JUL 22, 2002 JUL NEWA -A- AP EQ 5MG BASE/ML N75857 002 JUL 22, 2002 JUL NEWA MIDODRINE HYDROCHLORIDE TABLET; ORAL PROAMATINE -A- + SHIRE LABS 5MG N19815 002 SEP 06, 1996 JUL CRLD...
Microsoft Word - 75250wd.doc page 1
author: staufferp
Prescription and OTC Drug Product List 12/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 12: December 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE - ADD - BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE TABLET; ORAL - ADD - GEL; TOPICAL OXYCODONE AND ACETAMINOPHEN - ADD - BENZACLIN - ADD - AA WATSON...
http://www.fda.gov/cder/foi/appletter/2000/75117ltr.pdf ANDA 75- 117 December 14, 2000 Ascent Pediatrics Attention: William EOrapred (Prednisolone Sodium Phosphate Oral Solution...
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Corticosteroids for nephrotic syndrome - [Medication] - Quest Diagnostics Patient Health Library Corticosteroids for nephrotic syndrome Examples Brand Name Chemical Name Deltasone, Liquid Pred, Meticorten, Orasone, Prednicen-M, Sterapred, Sterapred DS prednisone Orapred, Pediapred, Prelone prednisolone How It Works Corticosteroids are strong anti-inflammatory medications.
Corticosteroids (glucocorticoids) for cancer and cancer pain - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Corticosteroids (glucocorticoids) for cancer and cancer pain - [Medication] - Quest Diagnostics Patient Health Library Corticosteroids (glucocorticoids) for cancer and cancer pain - [Medication] - Quest Diagnostics Patient Health Library Cancer, Cancer,...
Systemic corticosteroids for quick relief during acute asthma episodes - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Systemic corticosteroids for quick relief during acute asthma episodes - [Medication] - Quest Diagnostics Patient Health Library Systemic corticosteroids for quick relief during acute asthma episodes - [Medication] - Quest Diagnostics Patient Health Library...
http://www.biomarinpharm.com/Orapred%20PI%200501.pdf Orapred ® (prednisolone sodium phosphate oral solution) 45503- 08A Orapred ® (prednisolone sodium phosphate oral solution) 45503- 08A Orapred ® (prednisolone sodium phosphate oral solution) Rx only DESCRIPTION: Orapred Solution is a dye free, pale to light yellow solution.Orapred (20.2 mg...
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http://www.biomarinpharm.com/Orapred%20PI-2004-07-14.pdf Orapred ® (prednisolone sodium phosphate oral solution) 45502- 08B Orapred ® (prednisolone sodium phosphate oral solution) 45502- 08B Orapred ® (prednisolone sodium phosphate oral solution) Rx only DESCRIPTION Orapred Solution is a dye free, pale to light yellow solution.Orapred Solution is indicated in the...
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duplicates:http://www.biomarinpharm.com/docs/Orapred_PI.pdf
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duplicates:http://www.biomarinpharm.com/docs/Orapred_PI.pdf
THE MERCK MANUAL, Sec. 5, Ch. 55, Crystal-Induced Conditions This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 5.Phosphate And Other Crystal Disorde rs Gout A recurrent acute or chronic arthritis of peripheral joints that results from deposition in and about the...
http://www.merck.com/product/usa/pi_circulars/d/decadron/decadron_tblts_pi.pdf For the purpose of comparison, the following is the equivalent milligram dosage of the various corticosteroids: Cortisone, 25 Triamcinolone, 4 Hydrocortisone, 20 Paramethasone, 2 Prednisolone, 5 Betamethasone, 0.75 Prednisone, 5 Dexamethasone, 0.75 Methylprednisolone, 4 These dose relationships apply only to oral or intravenous administration of these compounds.
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Mercury in Drug and Biologic Products Retired Persons Oxymetazoline Nasal Spray PMA.002 - American International Chemical Thimerosal (bulk chemical) TM 100 - American International Chemical Thimerosal (bulk chemical) TM 100 - American International Chemical Thimerosal USP 97% (bulk chemical) TM 97 - American Pharmaceutical 12 Hour Nasal Solution PMA NS - Appletree Markets Long Lasting Nasal Spray PMA NS * Bausch & Lomb...
CDER Guidance Documents (Issued 8/2000, Posted 8/8/2000) Joint Safety/Efficacy (Multidisciplinary) (Draft) Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001) [ PDF ] M4 Common Technical Document--Quality: Questions and Answers/Location Issues [ HTML ] or [ PDF ] or [ ] (Issued 9/12/2002, Posted 12/30/2002) Quality Q1E Evaluation of...
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
THE MERCK MANUAL, Sec. 5, Ch. 55, Crystal-Induced Conditions This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 5Phosphate And Other Crystal Disorders Gout A recurrent acute or chronic arthritis of peripheral joints that results from deposition in and about the...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt SOTALOL HCL AS MFG & SOLD UNDER THE SIEGFRIED LABEL 3724 21-Feb-80 AVENTIS PHARMA SA "1,A,24-DIHYDROXYCHOLECALCIFEROL" 3725 07-Feb-80 DINAMITE DIPHARMA SPA ISOSORBIDE DINITRATE (ISDN) 3743 10-Mar-80 MEDI PHYSICS INC "CYCLOTRON OPERATION, INDIUM CL (IN 111)MANUFACTURED IN EMERYVILLE, CALIFORNIA." 3746 10-Mar-80 MEDI PHYSICS INC "CYCLOTRON OPERATION, THALLOUS CL (TL-201), NORTH...
