Home Applications 019758 Application 019758
Type NDA
Sponsor HERITAGE LIFE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLOZARIL CLOZAPINE TABLET;ORAL 25MG Yes No 002 CLOZARIL CLOZAPINE TABLET;ORAL 100MG Yes Yes 003 CLOZARIL CLOZAPINE TABLET;ORAL 50MG Yes No 004 CLOZARIL CLOZAPINE TABLET;ORAL 200MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N019758-001 CLOZARIL CLOZAPINE 25MG TABLET / ORAL AB RLD 1989-09-26 N019758-002 CLOZARIL CLOZAPINE 100MG TABLET / ORAL AB RLD, RS 1989-09-26 N019758-003 CLOZARIL CLOZAPINE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2019-05-20 N019758-004 CLOZARIL CLOZAPINE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2019-05-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 1 of 5 · 168 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 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019758-003 CLOZARIL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2019-05-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019758-004 CLOZARIL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2019-05-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019758-003 CLOZARIL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2019-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019758-004 CLOZARIL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2019-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019758-003 CLOZARIL 50MG TABLET / ORAL RLD 2019-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019758-004 CLOZARIL 200MG TABLET / ORAL RLD 2019-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019758-003 CLOZARIL 50MG TABLET / ORAL RLD 2019-05-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019758-004 CLOZARIL 200MG TABLET / ORAL RLD 2019-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019758-003 CLOZARIL 50MG TABLET / ORAL RLD 2019-05-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019758-004 CLOZARIL 200MG TABLET / ORAL RLD 2019-05-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019758-003 CLOZARIL 50MG TABLET / ORAL RLD 2019-05-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019758-004 CLOZARIL 200MG TABLET / ORAL RLD 2019-05-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019758-003 CLOZARIL 50MG TABLET / ORAL RLD 2019-05-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019758-004 CLOZARIL 200MG TABLET / ORAL RLD 2019-05-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019758-003 CLOZARIL 50MG TABLET / ORAL RLD 2019-05-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019758-004 CLOZARIL 200MG TABLET / ORAL RLD 2019-05-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019758-003 CLOZARIL 50MG TABLET / ORAL RLD 2019-05-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019758-004 CLOZARIL 200MG TABLET / ORAL RLD 2019-05-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019758-001 CLOZARIL 25MG TABLET / ORAL AB RLD 1989-09-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019758-002 CLOZARIL 100MG TABLET / ORAL AB RLD, RS 1989-09-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019758-003 CLOZARIL 50MG TABLET / ORAL RLD 2019-05-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019758-004 CLOZARIL 200MG TABLET / ORAL RLD 2019-05-20 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 144 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 · 47 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0781-5989 Clozapine clozapine Sandoz Inc. NDA Current 0781-5989 Clozapine clozapine Sandoz Inc. NDA Current 0781-5989 Clozapine clozapine Sandoz Inc. NDA Current 0781-5989 Clozapine clozapine Sandoz Inc. NDA Current 0781-5992 Clozapine clozapine Sandoz Inc. NDA Current 0781-5992 Clozapine clozapine Sandoz Inc. NDA Current 0781-5992 Clozapine clozapine Sandoz Inc. NDA Current 0781-5992 Clozapine clozapine Sandoz Inc. NDA Current 64725-1260 Clozaril clozapine TYA Pharmaceuticals NDA Current 69809-0126 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0126 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0126 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0126 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0126 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0126 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0126 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0127 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0127 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0127 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0127 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0127 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0127 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0127 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0130 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0130 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0130 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0130 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0130 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0135 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0135 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0135 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0135 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 69809-0135 Clozaril clozapine HLS Therapeutics (USA), Inc. NDA Current 72721-1725 Clozapine clozapine Heartwood Pharma NDA Current 72721-1725 Clozapine clozapine Heartwood Pharma NDA Current 72721-1725 Clozapine clozapine Heartwood Pharma NDA Current 72721-1725 Clozapine clozapine Heartwood Pharma NDA Current 72721-1750 Clozapine clozapine Heartwood Pharma NDA Current 72721-1750 Clozapine clozapine Heartwood Pharma NDA Current 72721-1750 Clozapine clozapine Heartwood Pharma NDA Current 72721-1760 Clozapine clozapine Heartwood Pharma NDA Current 72721-1760 Clozapine clozapine Heartwood Pharma NDA Current 72721-1760 Clozapine clozapine Heartwood Pharma NDA Current 72721-1760 Clozapine clozapine Heartwood Pharma NDA Current 72721-1770 Clozapine clozapine Heartwood Pharma NDA Current 72721-1770 Clozapine clozapine Heartwood Pharma NDA Current 72721-1770 Clozapine clozapine Heartwood Pharma NDA Current