Norethin 1/35e-28
Drug - Norethin 1/35e-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;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 Norethin 1/35e-28. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
071481
The FDA assigned number to Norethin 1/35e-28. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Norethin 1/35e-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 -
Apr 12, 1988
The date Norethin 1/35e-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 Norethin 1/35e-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 Norethin 1/35e-28 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 Norethin 1/35e-28.
Norethin 1/35e-28
Norethin 1/35e-28 0.035mg;1mg Tablet; Oral-28 Ovcon-50 0.05mg;1mg Tablet; Oral-21 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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