Prevents pregnancy. ANDA 76081, held by Barr. Ethinyl Estradiol; Norethindrone Acetate.
As of Nov 15, 2026, ANDA 76081 (Junel Fe 1/20), held by Barr, was first approved by FDA on Sep 18, 2003, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Junel 21 and Junel Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, 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 |
|---|---|---|---|
| Sep 18, 2003 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Junel Fe 1/200.02MG;1MG · tablet;oral-28 | Ethinyl Estradiol; Norethindrone Acetate | Rx |
| Sep 25, 2023 | Supplement 27Labeling · Standard review | Approved | None posted |
| Sep 25, 2023 | Supplement 30Labeling · Standard review | Approved | None posted |
| Aug 18, 2021 | Supplement 18Labeling · Standard review | Approved | None posted |
| Oct 20, 2004 | Supplement 3Labeling | Approved | None posted |
| Sep 18, 2003 | Original application | Approved | None posted |
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
