grepcent public filings, reorganized for comparison

VORICONAZOLE — FDA application ANDA205034

Application ANDA205034 · type ANDA · FDA status: approved · original approval 2016-04-13

Listed sponsor: AMNEAL PHARMS · AMRX 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

ProductFDA-listed trade nameActive ingredientDosage formRouteStrengthMarketing statusTE codeRLD
001VORICONAZOLEVORICONAZOLEFOR SUSPENSIONORAL200MG/5MLPrescriptionABNo

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.

Orange Book patent and exclusivity listings

No Orange Book patent or exclusivity listings joined to this application.

Compound cross-links

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

Related pages

Sponsor company · FDA-approved application index

Peer clusters: No published peer-cluster link for this sponsor.

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.