Home Applications 217628 Application 217628
Type NDA
Sponsor CARWIN PHARM ASSOC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLOTIC CLOTRIMAZOLE SOLUTION/DROPS;OTIC 1% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N217628-001 CLOTIC CLOTRIMAZOLE 1% SOLUTION/DROPS / OTIC RLD, RS 2025-09-26
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217628-001 12246006 2042-05-26 U-4276 Drug product 2025-10-10
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 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 N217628-001 CLOTIC 1% SOLUTION/DROPS / OTIC RLD, RS 2025-09-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217628-001 CLOTIC 1% SOLUTION/DROPS / OTIC RLD, RS 2025-09-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217628-001 CLOTIC 1% SOLUTION/DROPS / OTIC RLD, RS 2025-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217628-001 CLOTIC 1% SOLUTION/DROPS / OTIC RLD, RS 2025-09-26 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217628-001 CLOTIC 1% SOLUTION/DROPS / OTIC RLD, RS 2025-09-26 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 2026-09-14 22:38:34 2026-08 N217628-001 12246006 2042-05-26 U-4276 Drug product 2025-10-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217628-001 12246006 2042-05-26 U-4276 Drug product 2025-10-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217628-001 12246006 2042-05-26 U-4276 Drug product 2025-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217628-001 12246006 2042-05-26 U-4276 Drug product 2025-10-10 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217628-001 12246006 2042-05-26 U-4276 Drug product 2025-10-10 a50c72e98297…
Observed Orange Book exclusivity history# 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 83597 ORIG 2025-09-30 83573 ORIG 2025-09-26