Home Applications 209813 Application 209813
Type ANDA
Sponsor TEVA PHARMS USA INC Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209813-001 TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2026-08-17 A209813-002 TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 22MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2026-08-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2026-09-14 22:38:34 2026-08 A209813-001 TOFACITINIB CITRATE EQ 11MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2026-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209813-002 TOFACITINIB CITRATE EQ 22MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2026-08-17 84e616aacf4f…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A209813-001 AB 1 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209813-002 AB 1 84e616aacf4f…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.