Brevicon 28-day

   
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Brevicon 28-day


Drug - Brevicon 28-day
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; Norethindrone
Multiple ingredients are in alphabetical order.

Strength - 0.035MG;0.5MG
The potency of the active ingredient(s), Ethinyl Estradiol; Norethindrone. May repeat for multiple part products.

Applicant - WATSON LABS
The firm name holding legal responsibility for Brevicon 28-day. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017743
The FDA assigned number to Brevicon 28-day. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Brevicon 28-day. 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 - Approved Prior to Jan 1, 1982
The date Brevicon 28-day 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 Brevicon 28-day. 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 Brevicon 28-day is in. Format is RX, OTC, DISCN.

Applicant Full Name - Watson Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Brevicon 28-day.

Brevicon 28-day