EPOGEN/PROCRIT — FDA application BLA103234

Application BLA103234 · type BLA · FDA status: approved · original approval 1989-06-01

Listed sponsor: AMGEN · AMGN company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

Product	FDA-listed trade name	Active ingredient	Dosage form	Route	Strength	Marketing status	TE code	RLD
001	EPOGEN/PROCRIT	EPOETIN ALFA	VIAL	SINGLE-USE	10,000U/ML	Prescription	not listed	not listed
002	EPOGEN/PROCRIT	EPOETIN ALFA	VIAL	MULTIDOSE	20,000U/2ML	Prescription	not listed	not listed
003	EPOGEN/PROCRIT	EPOETIN ALFA	VIAL	MULTIDOSE	20,000/ML	Prescription	not listed	not listed
004	EPOGEN/PROCRIT	EPOETIN ALFA	VIAL	SINGLE-USE	2,000U/ML	Prescription	not listed	not listed
005	EPOGEN/PROCRIT	EPOETIN ALFA	VIAL	SINGLE-USE	3,000U/ML	Prescription	not listed	not listed
006	EPOGEN/PROCRIT	EPOETIN ALFA	VIAL	SINGLE-USE	40,000U/ML	Prescription	not listed	not listed
007	EPOGEN/PROCRIT	EPOETIN ALFA	VIAL	SINGLE-USE	4,000U/ML	Prescription	not listed	not listed

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

Patent/exclusivity listings: not applicable — the FDA Orange Book covers NDA and ANDA small-molecule applications, not BLA biologics.

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.