Home Applications 213464 Application 213464
Type NDA
Sponsor BAYER HEALTHCARE PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LAMPIT NIFURTIMOX TABLET;ORAL 30MG No No 002 LAMPIT NIFURTIMOX TABLET;ORAL 120MG No No
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 N213464-001 LAMPIT NIFURTIMOX 30MG TABLET / ORAL RLD 2020-08-06 N213464-002 LAMPIT NIFURTIMOX 120MG TABLET / ORAL RLD, RS 2020-08-06
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213464-001 ODE-319 2027-08-06 N213464-002 ODE-319 2027-08-06
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 1 of 2 · 74 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 2026-02-19 14:30 UTC 2026-02 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 87673890dc5c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 140 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50419-750 LAMPIT nifurtimox Bayer Healthcare Pharmaceuticals INC. NDA Current 50419-750 LAMPIT nifurtimox Bayer Healthcare Pharmaceuticals INC. NDA Current 50419-750 LAMPIT nifurtimox Bayer Healthcare Pharmaceuticals INC. NDA Current 50419-750 LAMPIT nifurtimox Bayer Healthcare Pharmaceuticals INC. NDA Current 50419-751 LAMPIT nifurtimox Bayer Healthcare Pharmaceuticals INC. NDA Current 50419-751 LAMPIT nifurtimox Bayer Healthcare Pharmaceuticals INC. NDA Current 50419-751 LAMPIT nifurtimox Bayer Healthcare Pharmaceuticals INC. NDA Current 50419-751 LAMPIT nifurtimox Bayer Healthcare Pharmaceuticals INC. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 74427 SUPPL 2023-06-06 74432 SUPPL 2023-06-05 73598 SUPPL 2023-02-23 73597 SUPPL 2023-02-23 70025 SUPPL 2022-02-01 70003 SUPPL 2022-01-31 64873 SUPPL 2020-10-07 64824 SUPPL 2020-10-05 64455 ORIG 2020-08-31 64232 ORIG 2020-08-07 64229 ORIG 2020-08-06