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Norethindrone And Ethinyl Estradiol (7/14) Drug - Norethindrone And Ethinyl Estradiol (7/14) 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,0.035MG;0.5MG,1MG 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 Norethindrone And Ethinyl Estradiol (7/14). The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 071042 The FDA assigned number to Norethindrone And Ethinyl Estradiol (7/14). Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Norethindrone And Ethinyl Estradiol (7/14). Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) Code - The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval Date - Sep 24, 1991 The date Norethindrone And Ethinyl Estradiol (7/14) 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 Norethindrone And Ethinyl Estradiol (7/14). 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 Norethindrone And Ethinyl Estradiol (7/14) 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 Norethindrone And Ethinyl Estradiol (7/14). Norethindrone And Ethinyl Estradiol (7/14) Norethin 1/35e-28 0.035mg;1mg Tablet; Oral-28 Norethindrone And Ethinyl Estradiol 0.035mg;0.5mg Tablet; Oral-28 Norethindrone And Ethinyl Estradiol 0.035mg;1mg Tablet; Oral-28 Norethindrone And Ethinyl Estradiol (10/11) 0.035mg,0.035mg;0.5mg,1mg Tablet; Oral-28 Norethindrone And Ethinyl Estradiol (7/14) 0.035mg,0.035mg;0.5mg,1mg Tablet; Oral-28 Brevicon 28-day 0.035mg;0.5mg Tablet; Oral-28 Gencept 10/11-28 0.035mg,0.035mg;0.5mg,1mg Tablet; Oral-28 Modicon 28 0.035mg;0.5mg Tablet; Oral-28 N.E.E. 1/35 28 0.035mg;1mg Tablet; Oral-28 Norcept-e 1/35 28 0.035mg;1mg Tablet; Oral-28 NewDrugInformation