Prevents pregnancy. ANDA 90947, held by Novast Labs Ltd. Ethinyl Estradiol; Norethindrone.
As of Nov 15, 2026, ANDA 90947 (Philith), held by Novast Labs Ltd, was first approved by FDA on Dec 22, 2011, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Oral contraceptives are 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 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 |
|---|---|---|---|
| Dec 22, 2011 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Philith0.035MG;0.4MG · tablet;oral-28 | Ethinyl Estradiol; Norethindrone | Rx |
| Apr 29, 2022 | Supplement 5Labeling · Standard review | Approved | None posted |
| Aug 9, 2017 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 22, 2011 | 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
