Arava
Drug - Arava
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) -
Leflunomide
Multiple ingredients are in alphabetical order.
Strength -
10MG
The potency of the active ingredient(s), Leflunomide. May repeat for multiple part products.
Applicant -
AVENTIS PHARMS
The firm name holding legal responsibility for Arava. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020905
The FDA assigned number to Arava. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Arava. 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 -
Sep 10, 1998
The date Arava 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 Arava. 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 Arava is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Aventis Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Arava.
Arava
Prevacid 15mg Tablet, Delayed Release, Orally Disintegrating; Oral Prevacid 30mg Tablet, Delayed Release, Orally Disintegrating; Oral Naprapac 250 (copackaged) 15mg,n/a;n/a,250mg Capsule, Delayed Rel Pellets; Tablet; Oral Naprapac 375 (copackaged) 15mg,n/a;n/a,375mg Capsule, Delayed Rel Pellets; Tablet; Oral Naprapac 500 (copackaged) 15mg,n/a;n/a,500mg Capsule, Delayed Rel Pellets; Tablet; Oral Fosrenol Eq 250mg Base Tablet, Chewable; Oral Fosrenol Eq 500mg Base Tablet, Chewable; Oral Xalatan 0.005% Solution/drops; Ophthalmic Arava 100mg Tablet; Oral Arava 10mg Tablet; Oral
NewDrugInformation
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