Bulimia Nervosa
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FDA label_change · 2023-08-18FDA Approved: FLUOXETINE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC)
FDA approved a supplemental application for Fluoxetine to update the labeling. The applicant is Chartwell Governmental & Specialty RX, LLC.
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FDA label_change · 2021-09-21FDA Approved: FLUOXETINE — Supplemental Application (ScieGen Pharmaceuticals, Inc)
FDA approved a supplemental application for fluoxetine by ScieGen Pharmaceuticals to update the labeling for this generic antidepressant.
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FDA label_change · 2016-12-28FDA Approved: FLUOXETINE — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental application for fluoxetine from Dr. Reddy's Laboratories Limited, indicating a labeling-related update to the ge…
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FDA label_change · 2016-01-10FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for fluoxetine from Teva Pharmaceuticals USA, Inc. to update the product labeling.
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FDA label_change · 2010-09-20FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)
FDA approved a supplemental application for fluoxetine hydrochloride by PAI Holdings to modify the product labeling.
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FDA label_change · 2009-03-30FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for Fluoxetine from Teva Pharmaceuticals USA, Inc., updating the labeling of the approved product.
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FDA label_change · 2006-09-20FDA Approved: PROZAC — Supplemental Application (Dista Products Company)
FDA approved a supplemental application for Prozac (fluoxetine hydrochloride) submitted by Dista Products Company, approving changes to the …