Home Applications 203109 Application 203109
Type NDA
Sponsor PFIZER Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 REVATIO SILDENAFIL CITRATE FOR SUSPENSION;ORAL EQ 10MG BASE/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203109-001 REVATIO SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL RLD 2012-08-30
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N203109-001 M-287 2026-01-31
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N203109-001 REVATIO EQ 10MG BASE/ML FOR SUSPENSION / ORAL RLD 2012-08-30 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-01 22:54:32 2026-06 N203109-001 M-287 2026-01-31 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0069-0336 Revatio sildenafil citrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0336 Revatio sildenafil citrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0336 Revatio sildenafil citrate Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0336 Revatio sildenafil citrate Pfizer Laboratories Div Pfizer Inc NDA Current 59762-2058 Sildenafil sildenafil citrate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-2058 Sildenafil sildenafil Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-2058 Sildenafil sildenafil citrate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-2058 Sildenafil sildenafil citrate Greenstone LLC NDA AUTHORIZED GENERIC Current