Prevents pregnancy. ANDA 91453, held by Novast Labs. Ethinyl Estradiol; Norethindrone Acetate.
As of Nov 15, 2026, ANDA 91453 (Larin Fe 1.5/30), held by Novast Labs, was first approved by FDA on Aug 23, 2013, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Microgestin Fe 1.5/30 is 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. 2
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 23, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Larin Fe 1.5/300.03MG;1.5MG · tablet;oral-28 | Ethinyl Estradiol; Norethindrone Acetate | Rx |
| Jul 17, 2023 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jul 17, 2023 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jul 31, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 23, 2013 | 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
