Home Applications 018714 Application 018714
Type NDA
Sponsor BAYER HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BILTRICIDE PRAZIQUANTEL TABLET;ORAL 600MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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date N018714-001 BILTRICIDE PRAZIQUANTEL 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1982-12-29
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 · 41 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 N018714-001 BILTRICIDE 600MG TABLET / ORAL RLD 1982-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018714-001 BILTRICIDE 600MG TABLET / ORAL RLD 1982-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018714-001 BILTRICIDE 600MG TABLET / ORAL RLD 1982-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018714-001 BILTRICIDE 600MG TABLET / ORAL RLD 1982-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018714-001 BILTRICIDE 600MG TABLET / ORAL RLD 1982-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018714-001 BILTRICIDE 600MG TABLET / ORAL RLD 1982-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018714-001 BILTRICIDE 600MG TABLET / ORAL RLD 1982-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD 1982-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018714-001 BILTRICIDE 600MG TABLET / ORAL RLD 1982-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018714-001 BILTRICIDE 600MG TABLET / ORAL RLD 1982-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD 1982-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD 1982-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 cb3db0bc1861…
Observed Orange Book normalized TE 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50419-747 Biltricide praziquantel Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-747 Biltricide praziquantel Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-747 Biltricide praziquantel Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-747 Biltricide praziquantel Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-747 Biltricide praziquantel Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-747 Biltricide praziquantel Bayer HealthCare Pharmaceuticals Inc. NDA Current 76413-146 Biltricide praziquantel Central Texas Community Health Centers NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 77090 SUPPL 2023-12-20 77089 SUPPL 2023-12-19 57333 SUPPL 2019-01-23 57154 SUPPL 2019-01-09 11294 SUPPL 2014-03-05 15113 SUPPL 2014-02-27 15112 SUPPL 2010-08-20 11293 SUPPL 2010-08-01 33571 SUPPL 2004-07-21 15111 SUPPL 2004-07-21 11292 SUPPL 2004-07-21 1045 SUPPL 2004-07-21