REVATIO — FDA application NDA021845
Listed sponsor: VIATRIS · VTRS 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 | REVATIO | SILDENAFIL CITRATE | TABLET | ORAL | EQ 20MG BASE | Prescription | AB | Yes |
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
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Exclusivity M-287 | 001 | listed exclusivity date: 2026-01-31 | FDA code as listed |
| Exclusivity ODE-469 | 001 | listed exclusivity date: 2030-01-31 | FDA code as listed |
Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.
Compound cross-links
- SILDENAFIL CITRATE · UNII BW9B0ZE037 · lmmol compound DEIYFTQMQPDXOT-UHFFFAOYSA-N · CHEMBL1737
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.