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VENLAFAXINE HYDROCHLORIDE — FDA application ANDA079098

Application ANDA079098 · type ANDA · FDA status: approved · original approval 2010-05-11

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
001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDETABLETORALEQ 25MG BASEDiscontinuednot listedNo
002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDETABLETORALEQ 37.5MG BASEDiscontinuednot listedNo
003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDETABLETORALEQ 50MG BASEDiscontinuednot listedNo
004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDETABLETORALEQ 75MG BASEDiscontinuednot listedNo
005VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDETABLETORALEQ 100MG BASEDiscontinuednot listedNo

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.