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FDA Approval Activities for this Drug…
Reminyl (galantamine hydrobromide) Tablets & Suspension, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. NDA 21-169/S-007 & 21-224/S-005 1/30/03 9/9/03 Reminyl (galantamine hydrobromide) Tablets & Suspension, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. NDA 21-169/S-003 & 21-224/S-003 4/19/02 5/2/02 Reminyl (galantamine hydrobromide) Solution, Janssen Research Foundation NDA 21-224 6/22/01 11/6/01 11/6/01 3/5/02 Reminyl (galantamine hydrobromide) Tablets, Janssen Research Foundation NDA 21-169 2/28/01 4/9/01 8/16/01 12/18/01 Reminyl Indications: The treatment of mild to moderate dementia of the Alzheimer's type. | Reminyl (galantamine hydrobromide) Extended Release Capsules, Johnson & Johnson, Approval | Galantamine Hydrobromide Tablets, J & J Pharma, Labeling Revision | Galantamine Hydrobromide Oral Solution, J & J Pharma, Labeling Revision | Galantamine Hydrobromide Extended-Release Capsules, J & J Pharma, Labeling Revision | GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE; ORAL EQ 16MG BASE RAZADYNE ER JANSSEN | GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE; ORAL EQ 24MG BASE RAZADYNE ER JANSSEN | GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE; ORAL EQ 8MG BASE RAZADYNE ER JANSSEN | GALANTAMINE HYDROBROMIDE SOLUTION; ORAL 4MG/ML RAZADYNE JANSSEN PHARMA | GALANTAMINE HYDROBROMIDE TABLET; ORAL EQ 12MG BASE RAZADYNE JANSSEN PHARMA | GALANTAMINE HYDROBROMIDE TABLET; ORAL EQ 4MG BASE RAZADYNE JANSSEN PHARMA | GALANTAMINE HYDROBROMIDE TABLET; ORAL EQ 8MG BASE RAZADYNE JANSSEN PHARMA | Razadyne Tablets, Johnson & Johnson, Labeling Revision | Razadyne Oral Solution, Johnson & Johnson, Labeling Revision | Razadyne Extended-Release Capsules, Johnson & Johnson, Labeling Revision | Galantamine Hydrobromide Tablets, Watson Labs, Tentative Approval | Galantamine Hydrobromide Tablets, Apotex Inc., Tentative Approval | Galantamine Hydrobromide Tablets, Actavis Elizabeth, Tentative Approval | Galantamine Hydrobromide Tablets, Dr. Reddy’s Labs, Tentative Approval | Galantamine Hydrobromide Tablets, Sandoz Inc., Tentative Approval | Galantamine Hydrobromide Tablets, Par Pharma, Tentative Approval | Galantamine Hydrobromide Tablets, Roxane Labs, Tentative Approval | Galantamine Hydrobromide Tablets, Alphapharm, Tentative Approval | Galantamine Hydrobromide Oral Solution, Roxane Labs, Tentative Approval | Galantamine Hydrobromide Tablets, Mylan Pharma, Tentative Approval | Galantamine Hydrobromide Tablets, Teva Pharma, Tentative Approval | Galantamine Hydrobromide Oral Solution, Ranbaxy Labs, Tentative Approval | Galantamine Hydrobromide Tablets, Alphapharm Party, Ltd., Approval | Galantamine Hydrobromide Tablets, Barr Laboratories, Inc., Approval | Galantamine Hydrobromide Extended-Release Capsules, Barr Laboratories, Inc., Approval | Galantamine Hydrobromide Tablets, Dr. Reddy's Laboratories, Ltd., Approval | Galantamine Hydrobromide Extended-release Capsules , Barr Laboratories, Inc., Approval | Galantamine Hydrobromide Extended-Release Capsules, Watson Laboratories, Inc., Approval | Galantamine Hydrobromide Oral Solution, Roxane Laboratories, Inc., Approval | Galantamine Hydrobromide Tablets, Par Pharmaceutical, Inc., Approval | Galantamine Hydrobromide Tablets, Roxane Laboratories, Inc., Approval | Galantamine Hydrobromide Extended-Release Capsules, IMPAX Laboratories, Inc., Tentative Approval | Galantamine Hydrobromide Extended-Release Capsules, IMPAX Laboratories, Inc., Approval | Galantamine Hydrobromide Tablets, Sandoz Inc., Approval | Galantamine Hydrobromide Tablets, TEVA Pharmaceuticals, Approval | Galantamine Hydrobromide Extended-Release Capsules, Mylan Pharmaceuticals Inc., Approval | Galantamine Hydrobromide Extended-Release Capsules, Sun Pharma, Approval | Galantamine Hydrobromide Tablets, Zydus Pharmaceuticals, Approval | Galantamine Hydrobromide Tablets, Aurobindo Pharma Ltd., Approval | Galantamine Hydrobromide Tablets, Apotex, Inc., Approval
  
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