Application 021590
- Type
- NDA
- Sponsor
- JAZZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FAZACLO ODT | CLOZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 25MG | Yes | No |
| 002 | FAZACLO ODT | CLOZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 100MG | Yes | No |
| 003 | FAZACLO ODT | CLOZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 50MG | No | No |
| 004 | FAZACLO ODT | CLOZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 12.5MG | Yes | No |
| 005 | FAZACLO ODT | CLOZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 150MG | Yes | No |
| 006 | FAZACLO ODT | CLOZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 200MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021590-001 | FAZACLO ODT | CLOZAPINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2004-02-10 | |
| N021590-002 | FAZACLO ODT | CLOZAPINE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2004-02-10 | |
| N021590-003 | FAZACLO ODT | CLOZAPINE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2005-06-03 | |
| N021590-004 | FAZACLO ODT | CLOZAPINE | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-05-30 | |
| N021590-005 | FAZACLO ODT | CLOZAPINE | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2010-07-09 | |
| N021590-006 | FAZACLO ODT | CLOZAPINE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2010-07-09 |
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.
| 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 | N021590-001 | FAZACLO ODT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2004-02-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021590-002 | FAZACLO ODT | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2004-02-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021590-003 | FAZACLO ODT | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2005-06-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021590-004 | FAZACLO ODT | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-05-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021590-005 | FAZACLO ODT | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2010-07-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021590-006 | FAZACLO ODT | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2010-07-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021590-001 | FAZACLO ODT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2004-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021590-002 | FAZACLO ODT | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2004-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021590-003 | FAZACLO ODT | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2005-06-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021590-004 | FAZACLO ODT | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-05-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021590-005 | FAZACLO ODT | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2010-07-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021590-006 | FAZACLO ODT | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2010-07-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021590-001 | FAZACLO ODT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2004-02-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021590-002 | FAZACLO ODT | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2004-02-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021590-003 | FAZACLO ODT | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2005-06-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021590-004 | FAZACLO ODT | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-05-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021590-005 | FAZACLO ODT | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2010-07-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021590-006 | FAZACLO ODT | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2010-07-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021590-001 | FAZACLO ODT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2004-02-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021590-002 | FAZACLO ODT | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2004-02-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021590-003 | FAZACLO ODT | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021590-004 | FAZACLO ODT | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-05-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021590-005 | FAZACLO ODT | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2010-07-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021590-006 | FAZACLO ODT | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2010-07-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021590-001 | FAZACLO ODT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2004-02-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021590-002 | FAZACLO ODT | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2004-02-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021590-003 | FAZACLO ODT | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021590-004 | FAZACLO ODT | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-05-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021590-005 | FAZACLO ODT | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2010-07-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021590-006 | FAZACLO ODT | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2010-07-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021590-001 | FAZACLO ODT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2004-02-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021590-002 | FAZACLO ODT | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2004-02-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021590-003 | FAZACLO ODT | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021590-004 | FAZACLO ODT | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-05-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021590-005 | FAZACLO ODT | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2010-07-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021590-006 | FAZACLO ODT | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2010-07-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021590-001 | FAZACLO ODT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2004-02-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021590-002 | FAZACLO ODT | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2004-02-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021590-003 | FAZACLO ODT | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-06-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021590-004 | FAZACLO ODT | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2007-05-30 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021590-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021590-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021590-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021590-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021590-006 | AB | 1 | 74a2ff9319b5… |
| 2019-09-15 20:21 UTC | 2019-09 | N021590-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021590-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021590-004 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021590-005 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021590-006 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021590-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021590-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021590-004 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021590-005 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021590-006 | AB | 1 | ea99ee380514… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CLOZAPINE | CLOZAPINE | NorthStar Rx LLC | 61fe53d5-ed5c-4e45-9189-709d08d386cb | 2026-05-11 | Boxed warning, Warnings, Adverse reactions | CLOZAPINE |
| CLOZAPINE | CLOZAPINE | Cardinal Health 107, LLC | 7c748f8a-73ce-4bd3-aa30-9c66657f06ec | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | CLOZAPINE |
| Clozapine | CLOZAPINE | Mylan Pharmaceuticals Inc. | 883b5d43-0339-7dc1-f775-93791fb9b978 | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | CLOZAPINE |
| Clozapine | CLOZAPINE | Safecor Health, LLC | 09231d80-6343-4a34-bd5b-100c547fd3c9 | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | CLOZAPINE |
| Clozapine | CLOZAPINE | Safecor Health LLC | 0fa59238-f0a6-4d00-9d8d-df2a43718fc1 | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | CLOZAPINE |
| CLOZAPINE | CLOZAPINE | Major Pharmaceuticals | 9db7aefb-f607-4158-a310-181e631bc648 | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | CLOZAPINE |
| CLOZAPINE | CLOZAPINE | Aurobindo Pharma Limited | 5021d643-32d2-4167-b5d8-90870e68a787 | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | CLOZAPINE |
| Clozapine | CLOZAPINE | Mylan Institutional Inc. | d5c8a456-6f3c-4963-b321-4ed746f690e4 | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | CLOZAPINE |
| Clozapine | CLOZAPINE | Accord Healthcare Inc. | 25c0c6d5-f7b0-48e4-e054-00144ff8d46c | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | CLOZAPINE |
| Clozapine | CLOZAPINE | American Health Packaging | d36c298b-7292-46e0-898f-43d3e11c3cf4 | 2025-09-03 | Boxed warning, Warnings, Adverse reactions | CLOZAPINE |
| Clozapine | CLOZAPINE | Mylan Pharmaceuticals Inc. | 9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b219 | 2025-08-15 | Boxed warning, Warnings, Adverse reactions | CLOZAPINE |
| Clozapine | CLOZAPINE | Mylan Institutional Inc. | 976be6e3-a9db-49c6-9b02-1ab168cf17b1 | 2025-07-18 | Boxed warning, Warnings, Adverse reactions | CLOZAPINE |
| Clozapine | CLOZAPINE | Teva Pharmaceuticals USA, Inc. | 6fccf4f7-2e30-4272-9800-225aaef20584 | 2025-06-24 | Boxed warning, Warnings, Adverse reactions | CLOZAPINE |
| VERSACLOZ | CLOZAPINE | TruPharma LLC | 2592c9a8-fd74-4e0d-a895-b07b014cf355 | 2025-06-23 | Boxed warning, Warnings, Adverse reactions | CLOZAPINE |
| Clozaril | CLOZAPINE | HLS Therapeutics (USA), Inc. | 90876802-0e3a-44c9-9ff7-1754dfbe736a | 2025-06-06 | Boxed warning, Warnings, Adverse reactions | CLOZAPINE |
| Clozapine | CLOZAPINE | Aurobindo Pharma Limited | caf2d4a6-2a23-4992-a807-560c4204afc4 | 2025-06-05 | Boxed warning, Warnings, Adverse reactions | CLOZAPINE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-3010 | Clozapine | clozapine | Teva Pharmaceuticals USA Inc | NDA AUTHORIZED GENERIC | Current |
| 0093-3011 | Clozapine | clozapine | Teva Pharmaceuticals USA Inc | NDA AUTHORIZED GENERIC | Current |
| 0093-3012 | Clozapine | clozapine | Teva Pharmaceuticals USA Inc | NDA AUTHORIZED GENERIC | Current |
| 0093-3086 | Clozapine | clozapine | Teva Pharmaceuticals USA Inc | NDA AUTHORIZED GENERIC | Current |
| 0093-3086 | Clozapine | clozapine | Teva Pharmaceuticals USA Inc | NDA AUTHORIZED GENERIC | Current |
| 0093-3086 | Clozapine | clozapine | Teva Pharmaceuticals USA Inc | NDA AUTHORIZED GENERIC | Current |
| 0093-3086 | Clozapine | clozapine | Teva Pharmaceuticals USA Inc | NDA AUTHORIZED GENERIC | Current |
| 0093-3087 | Clozapine | clozapine | Teva Pharmaceuticals USA Inc | NDA AUTHORIZED GENERIC | Current |
| 0093-3087 | Clozapine | clozapine | Teva Pharmaceuticals USA Inc | NDA AUTHORIZED GENERIC | Current |
| 0093-3087 | Clozapine | clozapine | Teva Pharmaceuticals USA Inc | NDA AUTHORIZED GENERIC | Current |
| 0093-3087 | Clozapine | clozapine | Teva Pharmaceuticals USA Inc | NDA AUTHORIZED GENERIC | Current |
| 18860-101 | FazaClo | clozapine | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 18860-101 | FazaClo | clozapine | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 18860-101 | FazaClo | clozapine | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 18860-102 | FazaClo | clozapine | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 18860-102 | FazaClo | clozapine | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 18860-104 | FazaClo | clozapine | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 18860-104 | FazaClo | clozapine | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 18860-104 | FazaClo | clozapine | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 18860-105 | FazaClo | clozapine | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 18860-105 | FazaClo | clozapine | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 18860-106 | FazaClo | clozapine | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 18860-106 | FazaClo | clozapine | Jazz Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 62579 | SUPPL | 2020-04-15 |
| 62574 | SUPPL | 2020-04-15 |
| 57307 | SUPPL | 2019-01-22 |
| 47371 | SUPPL | 2017-03-02 |
| 47353 | SUPPL | 2017-02-27 |
| 37303 | SUPPL | 2015-10-22 |
| 28210 | SUPPL | 2015-10-02 |
| 37302 | SUPPL | 2015-09-16 |
| 37298 | SUPPL | 2015-09-16 |
| 28209 | SUPPL | 2015-09-16 |
| 28203 | SUPPL | 2015-09-16 |
| 24004 | ORIG | 2015-09-16 |
| 37301 | SUPPL | 2013-07-23 |
| 28207 | SUPPL | 2013-07-22 |
| 28208 | SUPPL | 2012-01-12 |
| 15843 | SUPPL | 2012-01-09 |
| 28206 | SUPPL | 2010-12-06 |
| 15842 | SUPPL | 2010-12-04 |
| 28205 | SUPPL | 2010-09-13 |
| 15841 | SUPPL | 2010-09-10 |
| 28204 | SUPPL | 2010-07-14 |
| 5812 | SUPPL | 2010-07-14 |
| 37300 | SUPPL | 2010-07-12 |
| 37299 | SUPPL | 2010-07-12 |
| 5811 | SUPPL | 2008-08-19 |
| 5810 | SUPPL | 2008-07-17 |
| 37297 | SUPPL | 2007-06-04 |
| 5809 | SUPPL | 2007-06-04 |
| 37296 | SUPPL | 2006-02-22 |
| 5808 | SUPPL | 2006-02-22 |
| 21751 | ORIG | 2005-10-06 |
| 28202 | SUPPL | 2005-08-16 |
| 15840 | SUPPL | 2005-08-15 |
| 5806 | SUPPL | 2005-08-15 |
| 37295 | SUPPL | 2005-06-10 |
| 5807 | SUPPL | 2005-06-10 |
| 28201 | SUPPL | 2004-09-07 |
| 28200 | SUPPL | 2004-06-23 |
| 15839 | ORIG | 2004-03-03 |
| 5805 | ORIG | 2004-02-27 |