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GALANTAMINE

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

 
 
 
 
 
 
 
 

 


 

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 | Razadyne, galantamine hydrobromide, Tablet; Oral, Janssen Pharms, Labeling Revision | Razadyne, galantamine hydrobromide, Solution; Oral, Janssen Pharms, Labeling Revision | Razadyne Er, galantamine hydrobromide, Capsule, Extended Release; Oral, Janssen Pharms, Labeling Revision | Razadyne, galantamine hydrobromide, Tablet; Oral, Janssen Pharms, Manufacturing Change or Addition | Razadyne, galantamine hydrobromide, Solution; Oral, Janssen Pharms, Manufacturing Change or Addition | Razadyne Er, galantamine hydrobromide, Capsule, Extended Release; Oral, Janssen Pharms, Manufacturing Change or Addition | Razadyne, galantamine hydrobromide, Tablet; Oral, Janssen Pharms, Labeling Revision | Razadyne, galantamine hydrobromide, Solution; Oral, Janssen Pharms, Labeling Revision | Razadyne Er, galantamine hydrobromide, Capsule, Extended Release; Oral, Janssen Pharms, Labeling Revision

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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