Hydroxyprogesterone Caproate

Sold as Delalutin, Hydroxyprogesterone Caproate. Every FDA application for this active ingredient: 4 branded and 4 generic.

As of Nov 13, 2026, FDA lists 8 applications for Hydroxyprogesterone Caproate (sold as Delalutin, Hydroxyprogesterone Caproate), first approved Dec 26, 1974, with 14 new uses approved and 0 published complete response letters.

First approved: Dec 26, 1974
Applications: 8
New uses approved: 14
Complete response letters: 0

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Cycle-to-cycle Variability of Progesterone in the Endometrium in Patients Undergoing an Euploid Blastocyst Transfer in a Hormone Replacement Therapy (HRT) Cycle (PROMICOFET)Fertility, Implantation, Embryo · University Hospital, Ghent	Phase 4	Not yet recruiting	Sep 14, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Dec 26, 1974	Hydroxyprogesterone CaproateNDA 17439 · New formulation or manufacturer	Allergan	75	Discontinued
Aug 24, 2015	Hydroxyprogesterone CaproateANDA 200271	Aspen Global Inc	0	Discontinued
May 9, 2019	Hydroxyprogesterone CaproateANDA 211142	Eugia Pharma	1	Discontinued
—	Hydroxyprogesterone CaproateANDA 89330	Quad Pharms	0	Discontinued
—	Hydroxyprogesterone CaproateANDA 89331	Quad Pharms	0	Discontinued
—	DelalutinNDA 10347	Bristol Myers Squibb	0	Discontinued
—	DelalutinNDA 16911	Bristol Myers Squibb	0	Discontinued
—	Hydroxyprogesterone CaproateNDA 18004	Epic Pharma LLC	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA