Application 020592
- Type
- NDA
- Sponsor
- LILLY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZYPREXA | OLANZAPINE | TABLET;ORAL | 2.5MG | Yes | No |
| 002 | ZYPREXA | OLANZAPINE | TABLET;ORAL | 5MG | Yes | Yes |
| 003 | ZYPREXA | OLANZAPINE | TABLET;ORAL | 7.5MG | Yes | No |
| 004 | ZYPREXA | OLANZAPINE | TABLET;ORAL | 10MG | Yes | No |
| 005 | ZYPREXA | OLANZAPINE | TABLET;ORAL | 15MG | Yes | No |
| 006 | ZYPREXA | OLANZAPINE | TABLET;ORAL | 20MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020592-001 | ZYPREXA | OLANZAPINE | 2.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 |
| N020592-002 | ZYPREXA | OLANZAPINE | 5MG | TABLET / ORAL | AB | RLD, RS | 1996-09-30 |
| N020592-003 | ZYPREXA | OLANZAPINE | 7.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 |
| N020592-004 | ZYPREXA | OLANZAPINE | 10MG | TABLET / ORAL | AB | RLD | 1996-09-30 |
| N020592-005 | ZYPREXA | OLANZAPINE | 15MG | TABLET / ORAL | AB | RLD | 1997-09-09 |
| N020592-006 | ZYPREXA | OLANZAPINE | 20MG | TABLET / ORAL | AB | RLD | 1997-09-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020592-001 | AB |
| N020592-002 | AB |
| N020592-003 | AB |
| N020592-004 | AB |
| N020592-005 | AB |
| N020592-006 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N020592-001 | ZYPREXA | 2.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N020592-002 | ZYPREXA | 5MG | TABLET / ORAL | AB | RLD, RS | 1996-09-30 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N020592-003 | ZYPREXA | 7.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N020592-004 | ZYPREXA | 10MG | TABLET / ORAL | AB | RLD | 1996-09-30 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N020592-005 | ZYPREXA | 15MG | TABLET / ORAL | AB | RLD | 1997-09-09 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N020592-006 | ZYPREXA | 20MG | TABLET / ORAL | AB | RLD | 1997-09-09 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N020592-001 | ZYPREXA | 2.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020592-002 | ZYPREXA | 5MG | TABLET / ORAL | AB | RLD, RS | 1996-09-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020592-003 | ZYPREXA | 7.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020592-004 | ZYPREXA | 10MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020592-005 | ZYPREXA | 15MG | TABLET / ORAL | AB | RLD | 1997-09-09 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020592-006 | ZYPREXA | 20MG | TABLET / ORAL | AB | RLD | 1997-09-09 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N020592-001 | ZYPREXA | 2.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020592-002 | ZYPREXA | 5MG | TABLET / ORAL | AB | RLD, RS | 1996-09-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020592-003 | ZYPREXA | 7.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020592-004 | ZYPREXA | 10MG | TABLET / ORAL | AB | RLD | 1996-09-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020592-005 | ZYPREXA | 15MG | TABLET / ORAL | AB | RLD | 1997-09-09 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020592-006 | ZYPREXA | 20MG | TABLET / ORAL | AB | RLD | 1997-09-09 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-001 | ZYPREXA | 2.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-002 | ZYPREXA | 5MG | TABLET / ORAL | AB | RLD, RS | 1996-09-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-003 | ZYPREXA | 7.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-004 | ZYPREXA | 10MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-005 | ZYPREXA | 15MG | TABLET / ORAL | AB | RLD | 1997-09-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-006 | ZYPREXA | 20MG | TABLET / ORAL | AB | RLD | 1997-09-09 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-001 | ZYPREXA | 2.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-002 | ZYPREXA | 5MG | TABLET / ORAL | AB | RLD, RS | 1996-09-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-003 | ZYPREXA | 7.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-004 | ZYPREXA | 10MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-005 | ZYPREXA | 15MG | TABLET / ORAL | AB | RLD | 1997-09-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-006 | ZYPREXA | 20MG | TABLET / ORAL | AB | RLD | 1997-09-09 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-001 | ZYPREXA | 2.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-002 | ZYPREXA | 5MG | TABLET / ORAL | AB | RLD, RS | 1996-09-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-003 | ZYPREXA | 7.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-004 | ZYPREXA | 10MG | TABLET / ORAL | AB | RLD | 1996-09-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-005 | ZYPREXA | 15MG | TABLET / ORAL | AB | RLD | 1997-09-09 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-006 | ZYPREXA | 20MG | TABLET / ORAL | AB | RLD | 1997-09-09 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-001 | ZYPREXA | 2.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-002 | ZYPREXA | 5MG | TABLET / ORAL | AB | RLD, RS | 1996-09-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-003 | ZYPREXA | 7.5MG | TABLET / ORAL | AB | RLD | 1996-09-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-004 | ZYPREXA | 10MG | TABLET / ORAL | AB | RLD | 1996-09-30 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N020592-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N020592-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N020592-003 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N020592-004 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N020592-005 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N020592-006 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N020592-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020592-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020592-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020592-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020592-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020592-006 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N020592-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020592-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020592-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020592-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020592-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020592-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020592-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020592-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020592-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020592-004 | AB | 1 | fd3edfee7708… |
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 |
|---|---|---|---|---|---|---|
| Olanzapine | OLANZAPINE | Direct_Rx | 22528ae1-e36f-48e1-e063-6294a90a3dd2 | 2024-09-17 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE |
| Olanzapine | OLANZAPINE | NorthStar RxLLC | ea3259d5-36ee-4ac9-b849-9625626e2187 | 2024-07-03 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE |
| Olanzapine | OLANZAPINE | Qilu Pharmaceutical Co., Ltd. | 6077f5c4-01d7-4c1d-97a0-cb859f98ce68 | 2024-06-28 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE |
| Olanzapine | OLANZAPINE | Proficient Rx LP | 024e8e9b-a4fc-4882-b080-c070467166a6 | 2024-01-01 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE |
| Olanzapine | OLANZAPINE | NorthStar RxLLC | f4e41c2c-d32d-40c2-8afb-b6df998ba6b0 | 2023-10-10 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE |
| Olanzapine | OLANZAPINE | Lannett Company, Inc. | 002dd00f-7946-ea4f-e063-6294a90a5916 | 2023-07-10 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE |
| Olanzapine | OLANZAPINE | Bryant Ranch Prepack | 09e48e71-4dd2-4538-91d7-5b284f6647d8 | 2023-03-29 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE |
| Olanzapine | OLANZAPINE | Proficient Rx LP | ce66d545-015b-41d5-80c3-964d78e36bfd | 2023-02-01 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE |
| Olanzapine | OLANZAPINE | Dr. Reddy's Laboratories Ltd. | 9a57a63e-f856-aafa-037a-c08f2fea6496 | 2022-10-03 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE |
| Olanzapine | OLANZAPINE | Proficient Rx LP | 1f4a2eaf-3a12-4ebe-b97f-0a7bfbc32572 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE |
| Olanzapine | OLANZAPINE | Proficient Rx LP | e40d54bf-7334-4418-8a87-ff85941adec1 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE |
| Olanzapine | OLANZAPINE | Proficient Rx LP | 61424fa3-b09a-4267-a208-a7c7c3f69fe5 | 2020-10-01 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE |
| Olanzapine | OLANZAPINE | Aphena Pharma Solutions - Tennessee, LLC | b6ec5610-b4a6-4646-954a-0fe8b1d3e143 | 2020-05-05 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE |
| Olanzapine | OLANZAPINE | Proficient Rx LP | 7772a4c2-1fb1-412b-9e3b-ef3d693517a2 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | OLANZAPINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0002-4112 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4112 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4112 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4112 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4112 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4112 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4115 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4115 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4115 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4115 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4115 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4115 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4116 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4116 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4116 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4116 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4116 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4116 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4117 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4117 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4117 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4117 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4117 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4117 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4415 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4415 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4415 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4415 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4415 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4415 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4420 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4420 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4420 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4420 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4420 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 0002-4420 | Zyprexa | Olanzapine | Eli Lilly and Company | NDA | Current |
| 21695-140 | Zyprexa | Olanzapine | Rebel Distributors Corp | NDA | Current |
| 21695-142 | Zyprexa | Olanzapine | Rebel Distributors Corp | NDA | Current |
| 21695-144 | Zyprexa | Olanzapine | Rebel Distributors Corp | NDA | Current |
| 49999-606 | Zyprexa | Olanzapine | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 52959-579 | Zyprexa | Olanzapine | H.J. Harkins Company, Inc. | NDA | Current |
| 55289-213 | Zyprexa | Olanzapine | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 68258-7090 | Zyprexa | Olanzapine | Dispensing Solutions, Inc. | NDA | Current |
| 68258-7091 | Zyprexa | Olanzapine | Dispensing Solutions, Inc. | NDA | Current |
| 68258-7092 | Zyprexa | Olanzapine | Dispensing Solutions, Inc. | NDA | Current |
| 68258-7093 | Zyprexa | Olanzapine | Dispensing Solutions, Inc. | NDA | Current |
| 70518-1465 | Zyprexa | Olanzapine | REMEDYREPACK INC. | NDA | Current |
| 70518-1465 | Zyprexa | Olanzapine | REMEDYREPACK INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84950 | SUPPL | 2026-02-05 |
| 84889 | SUPPL | 2026-02-03 |
| 84951 | SUPPL | 2026-01-30 |
| 81159 | SUPPL | 2025-02-07 |
| 80957 | SUPPL | 2025-02-05 |
| 62676 | SUPPL | 2020-04-24 |
| 62663 | SUPPL | 2020-04-24 |
| 62662 | SUPPL | 2020-04-24 |
| 62635 | SUPPL | 2020-04-22 |
| 62634 | SUPPL | 2020-04-22 |
| 62629 | SUPPL | 2020-04-22 |
| 60660 | SUPPL | 2019-10-24 |
| 60657 | SUPPL | 2019-10-24 |
| 60635 | SUPPL | 2019-10-23 |
| 53520 | SUPPL | 2018-03-29 |
| 53472 | SUPPL | 2018-03-28 |
| 47377 | SUPPL | 2017-03-02 |
| 47376 | SUPPL | 2017-03-02 |
| 47347 | SUPPL | 2017-02-27 |
| 47346 | SUPPL | 2017-02-27 |
| 45532 | SUPPL | 2016-10-14 |
| 45600 | SUPPL | 2016-10-07 |
| 34914 | SUPPL | 2015-07-24 |
| 12799 | SUPPL | 2015-01-09 |
| 2817 | SUPPL | 2014-12-23 |
| 12800 | SUPPL | 2013-07-30 |
| 2818 | SUPPL | 2013-07-30 |
| 41458 | SUPPL | 2012-03-16 |
| 41457 | SUPPL | 2012-03-16 |
| 41455 | SUPPL | 2012-03-16 |
| 20747 | SUPPL | 2012-03-16 |
| 20749 | SUPPL | 2012-01-27 |
| 44059 | ORIG | 2011-12-22 |
| 41456 | SUPPL | 2011-06-30 |
| 20748 | SUPPL | 2011-06-30 |
| 34913 | SUPPL | 2011-06-29 |
| 12798 | SUPPL | 2011-06-29 |
| 25267 | SUPPL | 2011-06-27 |
| 25266 | SUPPL | 2011-06-27 |
| 44452 | SUPPL | 2011-01-07 |
| 25265 | SUPPL | 2010-12-06 |
| 12797 | SUPPL | 2010-12-04 |
| 34912 | SUPPL | 2010-06-03 |
| 34911 | SUPPL | 2010-06-03 |
| 25264 | SUPPL | 2010-06-03 |
| 2816 | SUPPL | 2010-06-03 |
| 25263 | SUPPL | 2010-02-01 |
| 34910 | SUPPL | 2010-01-29 |
| 25260 | SUPPL | 2010-01-26 |
| 2813 | SUPPL | 2010-01-26 |
| 12794 | SUPPL | 2009-12-10 |
| 12793 | SUPPL | 2009-12-10 |
| 25262 | SUPPL | 2009-11-19 |
| 34909 | SUPPL | 2009-09-17 |
| 20746 | SUPPL | 2009-09-16 |
| 20745 | SUPPL | 2009-09-16 |
| 34908 | SUPPL | 2009-03-20 |
| 2815 | SUPPL | 2008-08-19 |
| 20743 | ORIG | 2007-11-19 |
| 25261 | SUPPL | 2007-07-10 |
| 12796 | SUPPL | 2007-07-10 |
| 12795 | SUPPL | 2007-07-10 |
| 2814 | SUPPL | 2007-07-10 |
| 41454 | SUPPL | 2007-07-06 |
| 20744 | SUPPL | 2007-04-11 |
| 25259 | SUPPL | 2006-12-28 |
| 34907 | SUPPL | 2006-12-04 |
| 2809 | SUPPL | 2006-09-18 |
| 34905 | SUPPL | 2006-08-29 |
| 2812 | SUPPL | 2006-03-01 |
| 34906 | SUPPL | 2006-02-28 |
| 25258 | SUPPL | 2006-02-22 |
| 12792 | SUPPL | 2006-02-22 |
| 12791 | SUPPL | 2006-02-22 |
| 2810 | SUPPL | 2006-02-22 |
| 2811 | SUPPL | 2005-09-15 |
| 25257 | SUPPL | 2005-08-08 |
| 25256 | SUPPL | 2005-06-29 |
| 41453 | SUPPL | 2004-04-15 |
| 12790 | SUPPL | 2004-01-22 |
| 2808 | SUPPL | 2004-01-22 |
| 2807 | SUPPL | 2003-07-28 |
| 34904 | SUPPL | 2003-07-10 |
| 52115 | SUPPL | 1900-01-01 |
| 52114 | SUPPL | 1900-01-01 |
| 52113 | SUPPL | 1900-01-01 |
| 52111 | SUPPL | 1900-01-01 |
| 52110 | SUPPL | 1900-01-01 |
| 52109 | SUPPL | 1900-01-01 |