Treats ovulatory dysfunction. ANDA 72196, held by Granata Bio Corp. Clomiphene Citrate.
As of Nov 15, 2026, ANDA 72196 (Milophene), held by Granata Bio Corp, was first approved by FDA on Dec 20, 1988, with 6 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 |
|---|---|---|---|
| Dec 20, 1988 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Milophene50MG · tablet;oral | Clomiphene Citrate | Rx |
| Aug 15, 2025 | Supplement 8Manufacturing | Approved | None posted |
| Jan 23, 1998 | Supplement 1Manufacturing | Approved | None posted |
| Jan 23, 1998 | Supplement 2Manufacturing | Approved | None posted |
| Jan 23, 1998 | Supplement 3Labeling | Approved | None posted |
| Jan 23, 1998 | Supplement 4Manufacturing | Approved | None posted |
| Jan 23, 1998 | Supplement 5Manufacturing | Approved | None posted |
| Dec 20, 1988 | 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
