Depakote Er

   
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Depakote Er


Drug - Depakote Er
The trade name of the product as shown on the labeling.

Dosage - TABLET, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Divalproex Sodium
Multiple ingredients are in alphabetical order.

Strength - EQ 500MG VALPROIC ACID
The potency of the active ingredient(s), Divalproex Sodium. May repeat for multiple part products.

Applicant - ABBOTT
The firm name holding legal responsibility for Depakote Er. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021168
The FDA assigned number to Depakote Er. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Depakote Er. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Aug 4, 2000
The date Depakote Er was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - Yes
The pioneer or innovator of Depakote Er. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Depakote Er is in. Format is RX, OTC, DISCN.

Applicant Full Name - Abbott Laboratories
The full name of the firm holding legal responsibility for the new application of Depakote Er.

Depakote Er