http://www.fda.gov/cder/orange/appendix_a.txt RTU IN PLASTIC CONTAINER, METRONIDAZOLE FLAGYL I.V., METRONIDAZOLE HYDROCHLORIDE FLAGYL, METRONIDAZOLE FLAREX, FLUOROMETHOLONE ACETATE FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE FLAVOXATE HCL, FLAVOXATE HYDROCHLORIDE FLAXEDIL, GALLAMINE TRIETHIODIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE FLEXICORT, HYDROCORTISONE FLOLAN, EPOPROSTENOL SODIUM...
1997 Warning Letters and Notice of Violation Letters to Pharmaceutical Companies Johnson DDMAC 9/24/1997 5/29/1998 Posicor (Mibefradil Dihyrdrochloride) Tablets Hoffman-La Roche DDMAC 9/5/1997 5/29/1998 Salagen (Pilo carpine HCl) MGI Pharma DDMAC 9/24/1997 5/29/1998 Site Inspection Gedeon Richter, Ltd DMPQ 9/5/1997 9/24/1997 Zocor (Simvastatin) Merck DDMAC 9/22/1997 5/29/1998 October 1997 Accolate (Zafirkulast) Tablets Zeneca Pharmaceuticals DDMAC 10/1/1997 5/22...
DOCUMENT INFORMATION PAGE 441 442 Overall Adverse Experiences With >3% Incidence on Fluticasone Propionate 443 in Controlled Clinical Trials With FLOVENT ROTADISK in Patients 4 Years 444 Previously Receiving Bronchodilators and/or Inhaled Corticosteroids 445 Adverse Event Placebo (n = 438) % FLOVENT 50 mcg Twice Daily (n = 255) % FLOVENT 100 mcg Twice Daily (n = 331) % FLOVENT ...
author: 599
DOCUMENT INFORMATION PAGE page 13
author: 599
DOCUMENT INFORMATION PAGE 1 PRODUCT INFORMATION 1 FLOVENT ® 44 mcg 2 (fluticasone propionate, 44 mcg) 3 Inhalation Aerosol 4 5 FLOVENT ® 110 mcg 6 (fluticasone propionate, 110 mcg) 7 Inhalation Aerosol 8 9 FLOVENT ® 220 mcg 10 (fluticasone propionate, 220 mcg) 11 Inhalation Aerosol 12 13 For Oral Inhalation Only 14 15 DESCRIPTION: The active component of FLOVENT 44 mcg...
author: 599
DOCUMENT INFORMATION PAGE page 12
author: 599
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...
FDA Drug Approvals List March 2001 Original Application #: 021082 Approval Date: 01-MAR-01 Trade Name: TAVIST ALLERGY/SINUS/HEADACHE Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET Applicant: NOVARTIS CONSUMER HEALTH INC Active Ingredient(s): ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE OTC/RX Status: OTC Indication(s): For temporary relief of symptoms associated with hay fever,...
DOCUMENT INFORMATION PAGE 437 438 Overall Adverse Experiences With >3% Incidence on Fluticasone Propionate 439 in Controlled Clinical Trials With FLOVENT ROTADISK in Patients 4 Years 440 Previously Receiving Bronchodilators and/ or Inhaled Corticosteroids 441 Adverse Event Placebo (n = 438) % FLOVENT 50 mcg Twice Daily (n = 255) % FLOVENT 100 mcg Twice Daily (n = 331) % ...
author: sandy barnes
DOCUMENT INFORMATION PAGE page 13
author: sandy barnes
DOCUMENT INFORMATION PAGE 1 PRODUCT INFORMATION 1 FLOVENT ® 44 mcg 2 (fluticasone propionate, 44 mcg) 3 Inhalation Aerosol 4 5 FLOVENT ® 110 mcg 6 (fluticasone propionate, 110 mcg) 7 Inhalation Aerosol 8 9 FLOVENT ® 220 mcg 10 (fluticasone propionate, 220 mcg) 11 Inhalation Aerosol 12 13 For Oral Inhalation Only 14 15 DESCRIPTION: The active component of FLOVENT 44 mcg...
author: sandy barnes
DOCUMENT INFORMATION PAGE page 11
author: sandy barnes
01-287 PhRMA NewMed WomenforPDF page 17
author: RL
02-178 PhRMA NewMed Afro Am9/4 page 15
author: RL
01-181 PhRMA NewMed Hispan 5/13 page 16
author: RL
01-194 PhRMA NewMed OlderAm9/6 page 14
author: RL
02-137 PhRMA NewMed OlderAm6/24 page 15
author: RL
Prescription and OTC Drug Product List 11/1997 Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 11: Jan '97 - Nov '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE AMANTADINE HYDROCHLORIDE TABLET; ORAL CAPSULE; ORAL PRECOSE - DLT - SYMADINE - DLT - BAYER 25MG N20482 004 - DLT - AB SOLVAY 100MG N71000 001 - DLT - MAY 29, 1997 - DLT - SEP 04,...
Prescription and OTC Drug Product List 9/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 9: September 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE - ADD - ARSENIC TRIOXIDE TABLET; ORAL - ADD - INJECTABLE; INJECTION HYDROCODONE BITARTRATE AND ACETAMINOPHEN - ADD - TRISENOX - ADD - AA MALLINCKRODT 325MG...
http://www.fda.gov/cder/mdi/labels/flovent.pdf Overall Adverse Experiences With >3% Incidence on Fluticasone Propionate in Controlled Clinical Trials With FLOVENT ROTADISK in Patients ³ ³4 Years Previously Receiving Bronchodilators and/ or Inhaled Corticosteroids Adverse Event Placebo (n = 438) % FLOVENT 50 mcg Twice Daily (n = 255) % FLOVENT 100 mcg Twice Daily (n = 331) % FLOVENT ...
http://www.fda.gov/cder/mdi/labels/flovent.pdf page 10
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...
DDPA March 1996 Drug and Device Product Approvals for March 1996 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-659 NORVIR ABBOTT RITONAVIR 01-MAR-96 (SOLUTION) ABBOTT PARK, IL 80MG/ML (1 P, H*) 60064 (ANTIVIRAL) [TREATMENT OF HIV INFECTION IN COMBINATION WITH NUCLEOSIDE ANALOGUES OR AS MONOTHERAPY] 20-680 NORVIR ABBOTT RITONAVIR 01-MAR-96 (CAPSULE) ABBOTT PARK, IL 100MG (3 P) 60064 ...
Drug Approvals for October 1997 Drug Approvals for October 1997 Definitions and Notes October 1997 Original New Drug Applications Original Application #: 020755 Approval Date: 31-OCT-97 Trade Name: CAVERJECT Chemical Type: 5 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PHARMACIA AND UPJOHN CO Active Ingredient(s): ALPROSTADIL OTC/RX Status: RX Indication(s): Provides for an aqueous formulation for...
Drug Approvals for September 1997 The development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program Original Application #: 020857 Approval Date: 26-SEP-97 Trade Name: COMBIVIR Chemical Type: 4 Therapeutic Potential: P Dosage Form: TABLET Applicant: GLAXO WELLCOME INC Active Ingredient(s): LAMIVUDINE; ZIDOVUDINE OTC/RX Status: RX Indication(s): Treatment...
