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...
http://www.fda.gov/cder/orange/appendix_a.txt SODIUM, AMINOSALICYLATE SODIUM PACERONE, AMIODARONE HYDROCHLORIDE PACLITAXEL, PACLITAXEL PAGITANE, CYCRIMINE HYDROCHLORIDE PAMELOR, NORTRIPTYLINE HYDROCHLORIDE PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PAMINE FORTE, METHSCOPOLAMINE BROMIDE PAMINE, METHSCOPOLAMINE BROMIDE PANCURONIUM BROMIDE, PANCURONIUM BROMIDE PANCURONIUM, PANCURONIUM BROMIDE PANDEL, HYDROCORTISONE PROBUTATE...
CDER Template - Replace Title Here Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - June 2002 - Generic Drug Name Generic Manufacturer Brand Name Approval Date- 1- AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, U 200 MG/28.5 MG (BASE)/5 ML, AND 400 MG/57 MG (BASE)/5 ML GENEVA PHARMACEUTICALS, INC
author: USERNAME
First-Time Generics - December 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - December 2002 - Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 AMANTADINE HYDROCHLORIDE TABLETS 100 MG UPSHER-SMITH LABORATORIES, INC
author: OGD
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_DEC_1998.HTML 9-Dec-1998 TRIDIL INJECTION Nitroglycerine Injection 18-537 S-015 Faulding 9-Dec-1998 EFFEXOR Venlafaxine Hydrochloride 20-151 S-009 Wyeth Ayerst 9-Dec-1998 NITROGLYCERIN IN DEXTROSE Nitroglycerin 19-970 S-009 Baxter Hlthcare 9-Dec-1998 REBETOL Interferon Alfa-2b, Recombinant Capsules 20-903 S-002 Schering Plough Res 9-Dec-1998 BRETHINE INJECTION Terbutaline Sulfate Injection 18-571...
Prescription and OTC Drug Product List 6/2002 -D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
Microsoft Word - 75250wd.doc page 1
author: staufferp
http://www.fda.gov/cder/foi/appletter/2002/75099APltr.PDF ANDA 75- 099 June 28, 2002 Morton Grove Pharmaceuticals, IncPrednisolone Sodium Phosphate Oral Solution,...
http://www.fda.gov/cder/foi/appletter/2002/75099APltr.PDF page 2
http://www.fda.gov/cder/foi/appletter/2002/75099APltr.PDF page 1
FDA Drug Approvals List- January 1998 Dosage Form: INJECTABLE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): GONADOTROPIN, CHORIONIC OTC/RX Status: RX Application #: 020729 Labeling Supplement#: 002 To Original New Drug Application Approval Date: 21-JAN-98 Trade Name: UNIRETIC Dosage Form: TABLET Applicant: SCHWARZ PHARMA INC Active Ingredient(s): HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE OTC/RX Status...
http://www.fda.gov/cder/foi/appletter/2000/75117ltr.pdf ANDA 75- 117 December 14, 2000 Ascent Pediatrics Attention: William EPrednisolone Sodium Phosphate Oral Solution), 15...
http://www.fda.gov/cder/foi/appletter/2000/75117ltr.pdf page 1
FDA Drug Approvals List- December 1998 Drug Approvals for December 1998 Definitions and Notes December 1998 Original New Drug Applications Original Application #: 020998 Approval Date: 31-DEC-98 Trade Name: CELEBREX Chemical Type: 1 Therapeutic Potential: P Dosage Form: CAPSULE Applicant: GD SEARLE AND CO Active Ingredient(s): CELECOXIB OTC/RX Status: RX Indication(s):For the signs and symptoms of osteoarthritis and...
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...
2003 Export Products List Alphabetical page 26
author: Lee S. Ehler
Export Products List by System July 2003 page 10
author: Lee S. Ehler
19157s11.PDF page 15
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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.
