Prevents pregnancy. ANDA 75478, held by Barr. Ethinyl Estradiol; Norethindrone.
As of Nov 15, 2026, ANDA 75478 (Nortrel 7/7/7), held by Barr, was first approved by FDA on Aug 30, 2002, with 6 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP, 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the NORPLANT System depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 30, 2002 | Original application | Approved |
| Nortrel 7/7/70.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG · tablet;oral-21 | Ethinyl Estradiol; Norethindrone | Rx |
| Nortrel 7/7/70.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG · tablet;oral-28 | Ethinyl Estradiol; Norethindrone | Rx |
| Apr 29, 2022 | Supplement 22Labeling · Standard review | Approved | None posted |
| Jul 6, 2020 | Supplement 18Labeling · Standard review | Approved | None posted |
| Aug 26, 2016 | Supplement 17Labeling · Standard review | Approved | None posted |
| Jan 20, 2015 | Supplement 15Labeling · Standard review | Approved | None posted |
| Dec 31, 2014 | Supplement 13Labeling · Standard review | Approved | None posted |
| Apr 20, 2004 | Supplement 3Labeling | Approved | None posted |
| Aug 30, 2002 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
