Treats ovulatory dysfunction. ANDA 216545, held by Rubicon Research. Clomiphene Citrate.
As of Nov 15, 2026, ANDA 216545 (Clomiphene Citrate), held by Rubicon Research, was first approved by FDA on Nov 12, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Clomiphene citrate is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiphene citrate therapy. Those patients most likely to achieve success with clomiphene therapy include patients with polycystic ovary syndrome (see WARNINGS: Ovarian Hyperstimulation Syndrome ), amenorrhea- galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology. Properly timed coitus in relationship to ovulation is important.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 12, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clomiphene Citrate50MG · tablet;oral | Clomiphene Citrate | Rx |
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
