Home Applications 215029 Application 215029
Type NDA
Sponsor MEDRX USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BONDLIDO LIDOCAINE SYSTEM;TOPICAL 10% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N215029-001 BONDLIDO LIDOCAINE 10% SYSTEM / TOPICAL RLD, RS 2025-09-24
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215029-001 NP 2028-09-24
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 2026-08-18 06:07:40 2026-07 N215029-001 BONDLIDO 10% SYSTEM / TOPICAL RLD, RS 2025-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215029-001 BONDLIDO 10% SYSTEM / TOPICAL RLD, RS 2025-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215029-001 BONDLIDO 10% SYSTEM / TOPICAL RLD, RS 2025-09-24 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215029-001 BONDLIDO 10% SYSTEM / TOPICAL RLD, RS 2025-09-24 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-18 06:07:40 2026-07 N215029-001 NP 2028-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215029-001 NP 2028-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215029-001 NP 2028-09-24 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215029-001 NP 2028-09-24 a50c72e98297…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Documents# Document, Submission type, Date table Document Submission type Date 83525 ORIG 2025-09-26 83531 ORIG 2025-09-24