2024-21680. Progynon Associates, et al.; Withdrawal of Approval of Four New Drug Applications

Table 1—Approved NDAs for Which Required Reports Have Not Been Submitted

Application No.	Drug	Holder
NDA 004652	ORETON (testosterone) Pellets for Subcutaneous Implantations, 75 milligrams (mg)	Progynon Associates, 9300 Wilshire Blvd., Beverly Hills, CA 90212.
NDA 013268	WINSTEROID (stanozolol) Tablets, 2 mg	Sterling Winthrop Inc., 90 Park Ave., New York, NY 10016.
NDA 017455	Copper T Model TCu 200B (copper) Intrauterine Device	Duramed Research, Inc., 425 Privet Rd., Horsham, PA 19044.
NDA 205003	PRESTALIA (amlodipine besylate/perindopril arginine) Tablets, equivalent to (EQ) 2.5 mg base/3.5mg, EQ 5 mg base/7 mg, and EQ 10 mg base/14 mg	Adhera Therapeutics, Inc., 224 Holding Ave., Wake Forest, NC 27588.