Kelnor

   
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Kelnor


Drug - Kelnor
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) - Ethinyl Estradiol; Ethynodiol Diacetate
Multiple ingredients are in alphabetical order.

Strength - 0.035MG;1MG
The potency of the active ingredient(s), Ethinyl Estradiol; Ethynodiol Diacetate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 076785
The FDA assigned number to Kelnor. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Kelnor. 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 - May 23, 2005
The date Kelnor 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 Kelnor. 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 Kelnor 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 Kelnor.

Kelnor