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FDA Approval Activities for this Drug…
Entocort EC (Budesonide) Capsules, 3 mg, AstraZeneca LP NDA 21-324/S4 3/13/03 3/26/03 Entocort EC (Budesonide) Capsules, 3 mg, AstraZeneca LP NDA 21-324/S3 10/3/02 10/11/01 Entocort EC (Budesonide) Capsules, AstraZeneca LP NDA 21-324/S1 8/9/02 8/30/02 Entocort EC (Budesonide) Capsules, AstraZeneca LP NDA 21-324 10/2/01 1/28/02 1/28/02 1/28/02 Entocort Indications: Treatment of mild to moderate active Crohn's Disease involving the ileum and/or ascending colon. Pulmicort Turbuhaler (budesonide inhalation powder), AstraZeneca NDA 20-441/S16 10/24/03 Pulmicort Turbuhaler (budesonide inhalation powder), Rhinocort Aqua (budesonide) Nasal Spray and Pulmicort Respules (budesnonide inhalation suspension), AstraZeneca NDA 20-441/S18 NDA 20-746/S11 NDA 20929/S15 9/26/03 9/30/03 9/30/03 Pulmicort (budesonide inhalation suspension) Respules, AstraZeneca NDA 20-929/S13 2/26/03 3/10/03 3/25/03 Pulmicort (budesonide inhalation suspension) Respules AstraZeneca LP NDA 20-929 8/9/00 8/17/00 8/17/00 Pulmicort (Budesonide Inhalation Powder) Turbuhaler, Astra L.P. NDA 20-441/ S012 12/31/01 2/12/02 Pulmicort Turbuhaler, 200 mg, once daily dosing *application for once daily dosing was approved ONLY for maintenance and NOT for initiation of therapy, Astra L.P. NDA 20-441/ SE2-002 10/9/98 10/13/98 10/13/98 5/24/01 Pulmicort Respules (budesonide inhalation suspension), Astra Zeneca NDA 20-929/S12 1/10/03 1/23/03 Pulmicort Respules (budesonide inhalation suspension), Astra Zeneca NDA 20-929 8/8/00 8/9/00 8/9/00 Pulmicort Indications: for the maintenance treatment of asthma and as propylactic therapy in children 12 months to 8 years of age. Rhinocort Aqua (budesonide) Nasal Spray, AstraZeneca NDA 20-746 10/1/99 10/4/99 10/4/99 6/19/01 Rhinocort Aqua (budesonide) Nasal Spray, AstraZeneca LP NDA 20-746/S4 10/26/01 11/6/01 Rhinocort Indicated: for the management of nasal symptoms of seasonal or perennial allergic rhinitis in adults and children six years of age and older. Pulmicort Turbuhaler (budesonide inhalation powder), AstraZeneca Pulmicort Turbuhaler (budesonide inhalation powder), AstraZeneca Rhinocort Aqua (budesonide) Nasal Spray, AstraZeneca Rhinocort Aqua (budesonide) Nasal Spray, AstraZeneca, Efficacy Supplement with Clinical Data to Support Rhinocort Aqua (budesonide) Nasal Spray, AstraZeneca, Labeling Revision | Entocort(R) EC (budesonide) Capsules, AstraZeneca, Patient Population Altered | Pulmicort Respules (budesonide inhalation suspension), AstraZeneca Pharma, Efficacy Supplement w/clinical Data | Pulmicort Respules (budesonide) Suspension, AstraZeneca, Control Supplement | SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol, AstraZeneca Pharma, Approval | Budesonide Inhalation Powder, AstraZeneca, Labeling Revision
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