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FDA Approval Activities for this Drug…
Advair Diskus (fluticasone propionate/salmeterol) Inhalation Powder, GlaxoSmithKline NDA 21-077/S19 8/11/03 8/15/03 8/15/03 Advair Diskus (fluticasone propionate/salmeterol) Inhalation Powder, GlaxoSmithKline NDA 21-077/S8 8/21/02 8/26/02 Advair Diskus,100/50, 250/50 and 500/50, Glaxo Wellcome. NDA 21-077 Cutivate (fluticasone propionate) Cream, 0.05%, GlaxoSmithKline NDA 19-958/S13 4/16/02 4/22/02 4/18/02 Cutivate (fluticasone propionate cream) Cream, 0.005%, Glaxo Wellcome NDA 19-958-SE5-008 6/17/99 6/22/99 6/22/99 7/3/00 Cutivate Indication: A medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. (This supplement provides for use in pediatric patients ages 3 months and older.) Cutivate (fluticasone propionate) Ointment, 0.005%, GlaxoSmithKline NDA 19-957/S11 1/18/02 2/5/02 2/5/02 Cutivate (fluticasone propionate) Ointment GlaxoSmithKline NDA 19-957/S7 & S/9 Flonase Nasal Spray, 50 mcg, GlaxoSmithKline NDA 20-121/S28 5/1/03 7/9/03 Flonase Nasal Spray, 50 mcg, GlaxoSmithKline, NDA 20-121/S23 5/23/02 6/3/02 Flonase (fluticasone propionate) Nasal Spray, GlaxoSmithKline, NDA 20-121/S11, S13, & S20 5/9/02 5/21/02 Flonase (fluticasone propionate) Nasal Spray, 50 mcg, GlaxoWellcome NDA 20-121/S-009 12/11/98 12/14/98 9/14/01 Flonase Indication: For perennial nonallergic rhinitis for ages 4 and above. Flovent (fluticasone propionate) Inhalation Aerosol, GlaxoSmithKline NDA 20548/S19 10/8/03 10/16/03 10/16/03 Flovent (fluticasone propionate) Inhalation Aerosol, GlaxoSmithKline NDA 20548/S015/16 6/20/03 7/6/03 7/8/03 Flovent (fluticasone propionate inhalation powder) Rotadisk, GlaxoSmithKline NDA 20548/S14 10/8/03 Flovent (fluticasone propionate inhalation powder) Rotadisk Glaxo Wellcome NDA 20548/S008 & 20-549/S-002 12/22/98 5/23/01 Flovent (fluticasone propionate inhalation powder) Rotadisk Glaxo Wellcome NDA 20549/S-014 10/8/03 10/16/03 10/16/03 5/23/01 Flovent (Fluticasone Propionate) Inhalation Powder Rotadisk GlaxoSmithKline NDA 20-549/S11/S12 6/20/03 7/6/03 7/8/03 Flovent (fluticasone dipropionate inhalation powder) Rotadisk Glaxo Wellcome NDA 20-549/S-006 7/19/99 5/23/01 Flovent (fluticasone propionate inhalation powder) Rotadisk Glaxo Wellcome NDA 20-549/S-008 3/29/01 Flovent Diskus (fluticasone dipropionate inhalation powder). Glaxo Wellcome NDA 20-833/S-002 11/1/02 11/18/02 Flovent Diskus (fluticasone dipropionate inhalation powder). GlaxoSmithKline NDA 20-833/S-008 11/1/02 11/18/02 Flovent Diskus (fluticasone dipropionate) inhalation powder, 50mcg, 100mcg, 250mcg, GlaxoWellcome NDA 20-833 9/29/00 10/10/00 Indication: This new drug application provides for the use of Flovent Diskus 50 mcg, Flovent Diskus 100 mcg and Flovent Diskus 250 mcg (fluticasone propionate) Inhalation Powder for the maintenance treatment of asthma as prophylactic therapy in adults and pediatric patients 4 years of age and older. It is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of these patients may be Able to reduce or eliminate their requirement for oral corticosteroids over time. Fluticasone Propionate Ointment, 0.005%, Altana ANDA 76-300 FLUTICASONE PROPIONATE Aerosol, Metered; Inhalation 0.044MG/INH FLOVENT GLAXOSMITHKLINE | 020548 FLUTICASONE PROPIONATE Aerosol, Metered; Inhalation 0.11MG/INH FLOVENT GLAXOSMITHKLINE | 020548 FLUTICASONE PROPIONATE Aerosol, Metered; Inhalation 0.22MG/INH FLOVENT GLAXOSMITHKLINE | 019958 FLUTICASONE PROPIONATE Cream; Topical 0.05% CUTIVATE GLAXOSMITHKLINE | 019957 FLUTICASONE PROPIONATE Ointment; Topical 0.005% CUTIVATE GLAXOSMITHKLINE | 020549 FLUTICASONE PROPIONATE Powder; Inhalation 0.044MG/INH FLOVENT GLAXOSMITHKLINE | 020833 FLUTICASONE PROPIONATE Powder; Inhalation 0.05MG/INH FLOVENT DISKUS 50 GLAXOSMITHKLINE | 020549 FLUTICASONE PROPIONATE Powder; Inhalation 0.088MG/INH FLOVENT GLAXOSMITHKLINE | 020833 FLUTICASONE PROPIONATE Powder; Inhalation 0.1MG/INH FLOVENT DISKUS 100 GLAXOSMITHKLINE | 020549 FLUTICASONE PROPIONATE Powder; Inhalation 0.22MG/INH FLOVENT GLAXOSMITHKLINE | 020833 FLUTICASONE PROPIONATE Powder; Inhalation 0.25MG/INH FLOVENT DISKUS 250 GLAXOSMITHKLINE | 020121 FLUTICASONE PROPIONATE Spray, Metered; Nasal 0.05MG/SPRAY FLONASE GLAXOSMITHKLINE | 021077 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE Powder; Inhalation 0.1MG/INH;EQ 0.05MG BASE/INH ADVAIR DISKUS 100/50 GLAXOSMITHKLINE | 021077 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE Powder; Inhalation 0.25MG/INH;EQ 0.05MG BASE/INH ADVAIR DISKUS 250/50 GLAXOSMITHKLINE | 021077 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE Powder; Inhalation 0.5MG/INH;EQ 0.05MG BASE/INH ADVAIR DISKUS 500/50 GLAXOSMITHKLINE Flonase Nasal Spray, Flovent Inhalation Aerosol & Rotadisk, GlaxoSmithKline | Fluticasone Propionate Cream, Atrix Laboratories, | Fluticasone Propionate Cream, Altana, Inc. | Fluticasone Propionate Cream, Atrix Laboratories | Fluticasone Propionate Cream, Clay-Park Labs, Inc. | Fluticasone Propionate Ointment, Altana, Inc. | Fluticasone Propionate Ointment, Clay-Park Labs, Inc. | Flovent HFA (fluticasone propionate HFA) Inhalation Aerosol, GlaxoSmithKline Fluticasone Propionate Cream, KV Pharmaceutical, Approval | Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder), GlaxoSmithKline, Labeling Revision | Flovent Diskus (fluticasone propionate) inhalation powder, GlaxoSmithKline, Control Supplement | CUTIVATE (fluticasone propionate) Lotion, GlaxoSmithKline, Approval | Fluticasone Propionate Ointment, Taro Pharma, Approval | Flovent Diskus (fluticasone propionate inhalation powder), GlaxoSmithKline, Labeling Revision | Flovent Diskus (fluticasone propionate inhalation powder), GlaxoSmithKline, Labeling Revision | Flovent HFA (fluticasone propionate Inhalation Aerosol, GlaxoSmithKline, Labeling Revision | Fluticasone Propionate Nasal Spray, Roxane Labs, Approval | Advair Diskus (fluticasone propionate and salmeterol inhalation powder), GlaxoSmithKline, Labeling Revision | Flovent HFA Inhalation Aerosol, GSK, Patient Population Altered | Fluticasone Propionate Ointment, G & W Labs, Approval | Advair HFA (fluticasone propionate and salmeterol xinafoate) Inhalation Aerosol, GlaxoSmithKline, Approval | Advair Diskus (fluticasone propionate and salmeterol xinafoate) inhalation powder, GlaxoSmithKline, Labeling Revision | Flovent HFA (fluticasone propionate) Inhalation Aerosol, GlaxoSmithKline, Control Supplement | Advair Diskus (fluticasone propionate and salmeterol inhalation powder), GlaxoSmithKline, Labeling Revision | Veramyst (Fluticasone Furoate) Nasal Spray, GlaxoSmithKline, Approval | Fluticasone Propionate Nasal Spray, Apotex, Approval | Fluticasone Propionate Nasal Spray, Hi-Tech Pharmacal, Approval | Advair HFA (fluticasone propionate and salmeterol xinafoate) Inhalation Aerosol, GlaxoSmithKline, Labeling Revision | Advair Diskus 100/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, New Dosage Regimen | Advair Diskus 250/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, New Dosage Regimen | Advair Diskus 500/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, New Dosage Regimen | Flovent HFA (fluticasone propionate) Inhalation Aerosol, GlaxoSmithKline, Labeling Revision | Veramyst (fluticasone furoate) Nasal Spray, GlaxoSmithKline, Supplement | Advair HFA (fluticasone propionate and salmeterol xinafoate) Inhalation Aerosol, GlaxoSmithKline, Labeling Revision
  
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