Is there a generic for Dromostanolone propionate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Dromostanolone propionate. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Dromostanolone propionate?

DROLBAN (NDA 012936, LILLY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Dromostanolone propionate are approved?

Dromostanolone propionate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Dromostanolone propionate

Dromostanolone propionate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:DROLBAN · NDA 012936

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
DROLBAN	LILLY	NDA 012936	—	Approved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Dromostanolone propionate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo