Kariva

   
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Kariva


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

Dosage - TABLET; ORAL-28
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Desogestrel; Ethinyl Estradiol
Multiple ingredients are in alphabetical order.

Strength - 0.15MG,N/A;0.02MG,0.01MG
The potency of the active ingredient(s), Desogestrel; Ethinyl Estradiol. May repeat for multiple part products.

Applicant - BARR
The firm name holding legal responsibility for Kariva. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075863
The FDA assigned number to Kariva. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Kariva. 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 - Apr 5, 2002
The date Kariva 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 Kariva. 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 Kariva is in. Format is RX, OTC, DISCN.

Applicant Full Name - Barr Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Kariva.

Kariva