Home Applications 203479 Application 203479
Type NDA
Sponsor TASMAN PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VERSACLOZ CLOZAPINE SUSPENSION;ORAL 50MG/ML 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 N203479-001 VERSACLOZ CLOZAPINE 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06
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 N203479-001 8057811 2028-05-01 Drug product 2019-11-15
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 · 42 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 2026-08-18 06:07:40 2026-07 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203479-001 VERSACLOZ 50MG/ML SUSPENSION / ORAL RLD, RS 2013-02-06 e64feba35796…
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 2026-08-18 06:07:40 2026-07 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N203479-001 8057811 2028-05-01 Drug product 2019-11-15 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 18860-121 VERSACLOZ Clozapine Jazz Pharmaceuticals, Inc. NDA Current 52817-601 VERSACLOZ Clozapine TruPharma, LLC NDA Current 52817-601 VERSACLOZ Clozapine TruPharma LLC NDA Current 52817-601 VERSACLOZ Clozapine TruPharma LLC NDA Current