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 Drug Recalls 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 ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com