Home Applications 216203 Application 216203
Type NDA
Sponsor LEXICON PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 INPEFA SOTAGLIFLOZIN TABLET;ORAL 200MG Yes No 002 INPEFA SOTAGLIFLOZIN TABLET;ORAL 400MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N216203-001 INPEFA SOTAGLIFLOZIN 200MG TABLET / ORAL RLD 2023-05-26 N216203-002 INPEFA SOTAGLIFLOZIN 400MG TABLET / ORAL RLD, RS 2023-05-26
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216203-001 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 N216203-001 8476413 2028-05-29 U-3628 Drug substance, Drug product 2023-06-22 N216203-001 8217156 2030-10-07 Drug substance, Drug product 2023-06-22 N216203-002 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 N216203-002 8476413 2028-05-29 U-3628 Drug substance, Drug product 2023-06-22 N216203-002 8217156 2030-10-07 Drug substance, Drug product 2023-06-22
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N216203-001 NCE 2028-05-26 N216203-002 NCE 2028-05-26
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 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N216203-001 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N216203-001 8476413 2028-05-29 U-3628 Drug substance, Drug product 2023-06-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N216203-001 8217156 2030-10-07 Drug substance, Drug product 2023-06-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N216203-002 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N216203-002 8476413 2028-05-29 U-3628 Drug substance, Drug product 2023-06-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N216203-002 8217156 2030-10-07 Drug substance, Drug product 2023-06-22 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 N216203-001 NCE 2028-05-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N216203-002 NCE 2028-05-26 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join INPEFA SOTAGLIFLOZIN Lexicon Pharmaceuticals, Inc. 1a46614e-05f6-421a-b6f4-d6f8760d643a 2026-01-29 Warnings, Adverse reactions Exact identifier application applno (NDA): 216203 application number: NDA216203
Documents# Document, Submission type, Date table Document Submission type Date 74613 ORIG 2023-06-23 74395 ORIG 2023-05-30 74390 ORIG 2023-05-30 74389 ORIG 2023-05-30