Norethindrone And Ethinyl Estradiol
Drug - Norethindrone And Ethinyl Estradiol
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 Norethindrone And Ethinyl Estradiol. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
070686
The FDA assigned number to Norethindrone And Ethinyl Estradiol. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Norethindrone And Ethinyl Estradiol. 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 -
Jan 29, 1987
The date Norethindrone And Ethinyl Estradiol 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. 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 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.
Norethindrone And Ethinyl Estradiol
Norethin 1/35e-28 0.035mg;1mg Tablet; Oral-28 Norethindrone And Ethinyl Estradiol 0.035mg;0.5mg Tablet; Oral-28 Tri-norinyl 21-day 0.035mg,0.035mg,0.035mg;0.5mg,1mg,0.5mg Tablet; Oral-21 Aranelle 0.035mg,0.035mg,0.035mg;0.5mg,1mg,0.5mg Tablet; Oral-28 Balziva-28 0.035mg;0.4mg 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
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