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FDA Approval Activities for this Drug…
Depakene Capsules, Syrup, Tablets, Sprinkle Capsules, and Depakote ER Tablets, Abbott NDA 18-081/S-038, 18-082/S-024, 18-723/S-029, 19-680/S-015, 20-593/S-009 & 21-168/S-003 12/12/02 1/29/03 Depakote ER (divalproex) Tablets, Abbott NDA 21-168/S7 8/14/03 8/15/03 9/25/03 Depakote ER (divalproex) Extended-Release Tablets, Abbott NDA 20-782 & 21-168/S4 12/20/02 1/29/03 4/4/03 Depakote ER (divalproex) Tablets, Abbott NDA 21-168/S1 5/31/02 6/3/02 5/31/02 Depakote ER (divalproex sodium extended-release) Tablets, 500mg, Abbott NDA 21-168 Divalproex Sodium Delayed-release Tablets,125 mg, 250 mg, and 500 mg, Torpharm ANDA 75-112 DIVALPROEX SODIUM Capsule, Delayed Rel Pellets; 125MG VALPROIC ACID DEPAKOTE Abbott 018723 DIVALPROEX SODIUM Tablet, Delayed Release; 125MG VALPROIC ACID DEPAKOTE Abbott 018723 DIVALPROEX SODIUM Tablet, Delayed Release; 250MG VALPROIC ACID DEPAKOTE Abbott 018723 DIVALPROEX SODIUM Tablet, Delayed Release; 500MG VALPROIC ACID DEPAKOTE Abbott 021168 DIVALPROEX SODIUM Tablet, Extended Release; 250MG VALPROIC ACID DEPAKOTE ER Abbott 021168 DIVALPROEX SODIUM Tablet, Extended Release; 500MG VALPROIC ACID DEPAKOTE ER Abbott | Divalproex Sodium, Zydus Pharma, Tentative Approval | Divalproex Sodium Extended Release Tablets, Ranbaxy, Tentative Approval | Depakote ER (divalproex sodium extended-release tablets), Abbott Labs, New or Modified Indication | Depakote (divalproex sodium) Delayed Release Tablets, Abbott Labs, Labeling Revision | Depakote (divalproex sodium) Sprinkle Capsules, Abbott Labs, Labeling Revision | Depakote ER (divalproex sodium) Extended Release Tablets, Abbott Labs, Labeling Revision | Divalproex Sodium, Teva Pharma, Tentative Approval | Divalproex Sodium Delayed-Release Tablets, Wockhardt Ltd., Tentative Approval | Divalproex Sodium Delayed-Release Tablets, Genpharm, Tentative Approval | Divalproex Sodium Delayed-Release Tablets, Apotex, Tentative Approval | Depakote Sprinkle Capsules, Abbott Labs, Labeling Revision | Divalproex Sodium Extended-Release Tablets, Mylan Pharma, Tentative Approval | Divalproex Sodium Extended-Release Tabelts, Zydus Pharma, Tentative Approval | Divalproex Sodium Delayed-Release Tablets, Upsher-Smith Labs, Tentative Approval | Divalproex Sodium Delayed-release Tablets, Sun Pharma, Tentative Approval | Divalproex Sodium Delayed-Release Tablets, Sandoz Inc., Tentative Approval | Divalproex Sodium Delayed-Release Tablets, Nu-Pharm, Inc., Tentative Approval | Divalproex Sodium Delayed Release Tablets, Zydus Pharmaceuticals, Tentative Approval | Depakote (divalproex sodium) Sprinkle Capsules, Abbott Labs, Patient Population Altered | Depakote ER (divalproex sodium) Extended-Release Tablets, Abbott Labs, Patient Population Altered | Divalproex Sodium Delayed-Release Tablets, Dr. Reddy's Laboratories, Ltd., Approval | Divalproex Sodium Delayed-Release Tablets, Genpharm, ULC, Approval | Divalproex Sodium Delayed-Release Tablets, Lupin Pharmaceuticals, Inc., Approval | Divalproex Sodium Delayed-Release Tablets, Nu-Pharm, Inc., Approval | Divalproex Sodium Delayed-Release Tablets, Sandoz, Inc., Approval | Divalproex Sodium Delayed-Release Tablets, Sun Pharmaceutical Industries, Ltd., Approval | Divalproex Sodium Delayed-Release Tablets, Teva Pharmaceuticals USA, Approval | Divalproex Sodium Delayed-Release Tablets, Upsher-Smith Laboratories, Inc., Approval | Divalproex Sodium Delayed-Release Tablets, Anchen Pharmaceuticals, Inc., Approval | Divalproex Sodium Delayed-release Tablets, Orchid Healthcare, Approval | Divalproex Sodium Delayed Release Capsules, Dr. Reddy’s Laboratories Ltd., Approval | Divalproex Sodium Delayed-Release Capsules, Zydus Pharmaceuticals USA Inc., Approval | Divalproex Sodium Delayed-Release Tablets, Mylan Pharmaceuticals, Inc., Approval | Divalproex Sodium Extended-release Tablets, Wockhardt Limited, Approval | Divalproex Sodium Extended-Release Tablets, Anchen Pharmaceuticals (Taiwan), Inc., Approval | Divalproex Sodium Extended-Release Tablets, Zydus Pharmaceuticals USA Inc., Approval | Divalproex Sodium Delayed-Release Tablets, Zydus Pharmaceuticals USA Inc., Approval | Divalproex Sodium Delayed-Release Tablets, Mylan Pharmaceuticals, Inc., Approval | Depakote (divalproex sodium) Delayed-Release Capsules, Abbott Laboratories, Labeling Revision | Depakote (divalproex sodium) Delayed-Release Tablets, Abbott Laboratories, Labeling Revision | Depakote ER (divalproex sodium) Extended-Release Tablets, Abbott Laboratories, Labeling Revision | Divalproex Sodium Extended-Release Tablets, Impax Laboratories, Inc., Approval | Divalproex Sodium Extended-Release Tablets, Teva Pharmaceuticals, Approval | Divalproex Sodium Extended-Release Tablets, Zydus Pharmaceuticals USA Inc., Supplement | Divalproex Sodium Extended-Release Tablets, IMPAX Laboratories, Inc., Supplement | Divalproex Sodium Extended-Release Tablets, Anchen Pharmaceuticals, Inc., Supplement | Divalproex Sodium Extended-Release Tablets, Wockhardt Ltd., Supplement | Depakote (divalproex sodium) Extended-Release Tablets, Abbott Laboratories, Efficacy Supplement with Clinical Data to Support | Divalproex Sodium Delayed-Release Tablets, Vintage Pharmaceuticals, LLC, Approval | Divalproex Sodium Delayed-Release Tablets, Watson Laboratories, Inc., Approval | Divalproex Sodium Capsules, Mylan Pharmaceuticals Inc., Approval | Divalproex Delayed-Release Tablets, Unichem, Approval | Divalproex Sodium Delayed-Release Tablets, Aurobindo Pharma, Ltd., Approval | Depakote (divalproex sodium) Delayed-Release Tablets, Abbott Laboratories, Labeling Revision | Depakote (divalproex sodium) Delayed-Release Capsules, Abbott Laboratories, Labeling Revision | Depakote ER (divalproex sodium) Extended-Release Tablets, Abbott Laboratories, Labeling Revision
  
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