Clofibrate
Drug - Clofibrate
The trade name of the product as shown on the labeling.
Dosage -
CAPSULE; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Clofibrate
Multiple ingredients are in alphabetical order.
Strength -
500MG
The potency of the active ingredient(s), Clofibrate. May repeat for multiple part products.
Applicant -
TEVA
The firm name holding legal responsibility for Clofibrate. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
072600
The FDA assigned number to Clofibrate. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Clofibrate. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Jul 25, 1991
The date Clofibrate 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) -
No
The pioneer or innovator of Clofibrate. 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 Clofibrate is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Teva Pharmaceuticals Usa Inc
The full name of the firm holding legal responsibility for the new application of Clofibrate.
Clofibrate
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