Nortrel 0.5/35-28

   
Google
 
Web NewDrugInformation.com

Nortrel 0.5/35-28


Drug - Nortrel 0.5/35-28
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 - BARR
The firm name holding legal responsibility for Nortrel 0.5/35-28. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 072695
The FDA assigned number to Nortrel 0.5/35-28. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Nortrel 0.5/35-28. 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 - Feb 28, 1992
The date Nortrel 0.5/35-28 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 Nortrel 0.5/35-28. 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 Nortrel 0.5/35-28 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 Nortrel 0.5/35-28.

Nortrel 0.5/35-28