Mavik
Drug - Mavik
The trade name of the product as shown on the labeling.
Dosage -
TABLET; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Trandolapril
Multiple ingredients are in alphabetical order.
Strength -
4MG
The potency of the active ingredient(s), Trandolapril. May repeat for multiple part products.
Applicant -
ABBOTT
The firm name holding legal responsibility for Mavik. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020528
The FDA assigned number to Mavik. Format is nnnnnn.
Product Number -
003
The FDA assigned number to identify Mavik. 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 -
Apr 26, 1996
The date Mavik 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 Mavik. 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 Mavik 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 Mavik.
Mavik
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