Home Applications 217186 Application 217186
Type NDA
Sponsor IMPAX Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CREXONT CARBIDOPA; LEVODOPA CAPSULE, EXTENDED RELEASE;ORAL 35MG;140MG Yes No 002 CREXONT CARBIDOPA; LEVODOPA CAPSULE, EXTENDED RELEASE;ORAL 52.5MG;210MG Yes No 003 CREXONT CARBIDOPA; LEVODOPA CAPSULE, EXTENDED RELEASE;ORAL 70MG;280MG Yes No 004 CREXONT CARBIDOPA; LEVODOPA CAPSULE, EXTENDED RELEASE;ORAL 87.5MG;350MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217186-001 CREXONT CARBIDOPA; LEVODOPA 35MG;140MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2024-08-07 N217186-002 CREXONT CARBIDOPA; LEVODOPA 52.5MG;210MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2024-08-07 N217186-003 CREXONT CARBIDOPA; LEVODOPA 70MG;280MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2024-08-07 N217186-004 CREXONT CARBIDOPA; LEVODOPA 87.5MG;350MG CAPSULE, EXTENDED RELEASE / ORAL RLD, RS 2024-08-07
Orange Book patents# Current patent rows page 1 of 4 · 248 matching rows.
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.
Product history page 2 of 2 · 56 observed 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 2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217186-001 CREXONT 35MG;140MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2024-08-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217186-002 CREXONT 52.5MG;210MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2024-08-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217186-003 CREXONT 70MG;280MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2024-08-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217186-004 CREXONT 87.5MG;350MG CAPSULE, EXTENDED RELEASE / ORAL RLD, RS 2024-08-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217186-001 CREXONT 35MG;140MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2024-08-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217186-002 CREXONT 52.5MG;210MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2024-08-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217186-003 CREXONT 70MG;280MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2024-08-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217186-004 CREXONT 87.5MG;350MG CAPSULE, EXTENDED RELEASE / ORAL RLD, RS 2024-08-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217186-001 CREXONT 35MG;140MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2024-08-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217186-002 CREXONT 52.5MG;210MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2024-08-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217186-003 CREXONT 70MG;280MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2024-08-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217186-004 CREXONT 87.5MG;350MG CAPSULE, EXTENDED RELEASE / ORAL RLD, RS 2024-08-07 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217186-001 CREXONT 35MG;140MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2024-08-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217186-002 CREXONT 52.5MG;210MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2024-08-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217186-003 CREXONT 70MG;280MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2024-08-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217186-004 CREXONT 87.5MG;350MG CAPSULE, EXTENDED RELEASE / ORAL RLD, RS 2024-08-07 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 52 · 2,076 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N217186-001 10098845 2034-10-07 U-219 Drug product 2024-08-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 10292935 2034-10-07 U-219 Drug product 2024-08-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 10688058 2034-10-07 U-219 Drug product 2024-08-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 10973769 2034-10-07 U-219 Drug product 2024-08-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 10987313 2034-10-07 U-219 Drug product 2024-08-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 11357733 2034-10-07 Drug product 2024-08-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 11622941 2034-10-07 Drug product 2024-08-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 11666538 2034-10-07 U-219 Drug product 2024-08-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12064521 2034-10-07 Drug product 2024-08-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12128141 2034-10-07 U-219 Drug product 2024-11-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12178918 2034-10-07 Drug product 2025-01-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12178919 2034-10-07 U-219 Drug product 2025-01-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12274793 2034-10-07 Drug product 2025-05-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12303605 2034-10-07 Drug product 2025-06-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12403099 2034-10-07 Drug product 2025-09-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12491164 2034-10-07 Drug product 2026-01-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12691074 2034-10-07 Drug product 2026-07-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 11986449 2041-12-21 U-219 2024-08-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12109185 2041-12-21 U-1649 2024-10-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12109185 2041-12-21 U-219 2024-10-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12109185 2041-12-21 U-4004 2024-10-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12109185 2041-12-21 U-4005 2024-10-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12194150 2041-12-21 U-219 2025-01-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12201596 2041-12-21 U-1649 2025-02-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12201596 2041-12-21 U-4004 2025-02-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12201596 2041-12-21 U-4005 2025-02-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12263148 2041-12-21 U-1649 2025-04-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12263148 2041-12-21 U-4004 2025-04-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12263148 2041-12-21 U-219 2025-04-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12263148 2041-12-21 U-4005 2025-04-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12263149 2041-12-21 U-1649 2025-04-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12263149 2041-12-21 U-219 2025-04-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12263149 2041-12-21 U-4004 2025-04-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12263149 2041-12-21 U-4005 2025-04-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12295931 2041-12-21 U-1649 2025-06-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12295931 2041-12-21 U-4005 2025-06-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12295931 2041-12-21 U-4004 2025-06-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12295931 2041-12-21 U-219 2025-06-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12303481 2041-12-21 U-1649 2025-06-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217186-001 12303481 2041-12-21 U-219 2025-06-20 c2088c7a36db…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 56 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CREXONT CARBIDOPA AND LEVODOPA Amneal Pharmaceuticals LLC 095a08b6-b0b8-4f88-b759-67e8b87287a0 2026-05-29 Warnings, Adverse reactions Exact identifier application applno (NDA): 217186 application number: NDA217186
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 85971 SUPPL 2026-05-19 85963 SUPPL 2026-05-19 85493 SUPPL 2026-03-24 85455 SUPPL 2026-03-23 83870 ORIG 2025-10-22 79350 ORIG 2024-08-09 79345 ORIG 2024-08-08