Depacon
Drug - Depacon
The trade name of the product as shown on the labeling.
Dosage -
INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Valproate Sodium
Multiple ingredients are in alphabetical order.
Strength -
EQ 100MG BASE/ML
The potency of the active ingredient(s), Valproate Sodium. May repeat for multiple part products.
Applicant -
ABBOTT
The firm name holding legal responsibility for Depacon. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020593
The FDA assigned number to Depacon. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Depacon. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
AP
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Dec 30, 1996
The date Depacon 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 Depacon. 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 Depacon is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Abbott Laboratories Pharmaceutical Products Div
The full name of the firm holding legal responsibility for the new application of Depacon.
Depacon
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