Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.