Application 019010
- Type
- NDA
- Sponsor
- ABBVIE ENDOCRINE INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LUPRON | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019010-001 | LUPRON | LEUPROLIDE ACETATE | 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / SUBCUTANEOUS | RLD | 1985-04-09 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N019010-001 | LUPRON | 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / SUBCUTANEOUS | RLD | 1985-04-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019010-001 | LUPRON | 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / SUBCUTANEOUS | RLD | 1985-04-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019010-001 | LUPRON | 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / SUBCUTANEOUS | RLD | 1985-04-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019010-001 | LUPRON | 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / SUBCUTANEOUS | RLD | 1985-04-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019010-001 | LUPRON | 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / SUBCUTANEOUS | RLD | 1985-04-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019010-001 | LUPRON | 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / SUBCUTANEOUS | RLD | 1985-04-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019010-001 | LUPRON | 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / SUBCUTANEOUS | RLD | 1985-04-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019010-001 | LUPRON | 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / SUBCUTANEOUS | RLD | 1985-04-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019010-001 | LUPRON | 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / SUBCUTANEOUS | RLD | 1985-04-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019010-001 | LUPRON | 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / SUBCUTANEOUS | RLD | 1985-04-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019010-001 | LUPRON | 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / SUBCUTANEOUS | RLD | 1985-04-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019010-001 | LUPRON | 1MG/0.2ML | INJECTABLE / INJECTION | RLD | 1985-04-09 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019010-001 | LUPRON | 1MG/0.2ML | INJECTABLE / INJECTION | RLD | 1985-04-09 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N019010-001 | LUPRON | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1985-04-09 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| leuprolide acetate | LEUPROLIDE ACETATE | Amneal Pharmaceuticals LLC | 4838c674-044e-46b2-81e7-c691b99d8fa5 | 2026-05-28 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
| LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | Zydus Pharmaceuticals USA Inc. | 35634415-000f-47db-9bd7-9e16eef3f02e | 2026-05-25 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
| Leuprolide Acetate | LEUPROLIDE ACETATE | Sandoz Inc | 8bd72c1e-2751-4498-a346-bc5e3acbba0b | 2026-05-19 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
| LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | Eugia US LLC | 49a1d0c1-304c-46f2-a780-bd940ae1ced0 | 2026-05-08 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
| Vabrinty | LEUPROLIDE ACETATE | URONOVA PHARMACEUTICALS, INC. | 008776cc-83f1-4f8c-819b-6471425da15f | 2026-04-30 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
| Eligard | LEUPROLIDE ACETATE | TOLMAR Inc. | b7b679a9-6823-4ef8-8d31-3ab5058ffcfc | 2026-04-30 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
| leuprolide acetate | LEUPROLIDE ACETATE | Sun Pharmaceutical Industries, Inc. | a3b01473-30c7-4945-bd60-2484221aaaad | 2026-04-24 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
| Leuprolide Acetate | LEUPROLIDE ACETATE | Meitheal Pharmaceuticals Inc | d6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa584 | 2026-04-23 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
| leuprolide acetate | LEUPROLIDE ACETATE | UBI Pharma Inc. | cd46628f-055f-4da9-8c38-fa69af34eb4d | 2026-03-29 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
| Lupron Depot | LEUPROLIDE ACETATE | AbbVie Inc. | cbc8f94e-7330-4465-05ad-16d64493a5dd | 2026-03-15 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
| LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | Zydus Lifesciences Limited | 4bae0e2a-dd36-4987-85ee-36a52e642ec7 | 2026-02-09 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
| leuprolide acetate | LEUPROLIDE ACETATE | PAI Holdings, LLC dba PAI Pharma | 19be0b7f-e68a-4547-9e49-b51b12821907 | 2026-01-16 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
| Leuprolide Acetate | LEUPROLIDE ACETATE | VGYAAN Pharmaceuticals LLC | bec9077a-3f04-4887-856d-dde2de24584d | 2025-11-21 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
| Lupron Depot-PED | LEUPROLIDE ACETATE | AbbVie Inc. | e99f47d2-da10-3127-ecb3-e5d942ae6e81 | 2025-11-14 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
| Fensolvi | LEUPROLIDE ACETATE | TOLMAR Inc. | 2c311700-edf4-4f2a-a468-9875489a6cc7 | 2025-09-25 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
| Lupron Depot | LEUPROLIDE ACETATE | AbbVie Inc. | 00c486b0-bd7b-4898-834d-8c656e5e73cb | 2025-09-18 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
| Lupron Depot | LEUPROLIDE ACETATE | AbbVie Inc. | 60aad237-e1da-4705-cbbb-b3ca79e89ad8 | 2025-09-10 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
| Leuprolide Acetate | LEUPROLIDE ACETATE | NorthStar RxLLC | 0cf31b40-816b-d055-e063-6294a90af5d0 | 2025-06-24 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
| LUTRATE DEPOT | LEUPROLIDE ACETATE | Avyxa Pharma, LLC | 3a6d1373-17d9-4289-b62f-d299ffe55831 | 2025-06-03 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
| LEUPROLIDE ACETATE DEPOT | LEUPROLIDE ACETATE | CIPLA USA INC. | 1563a30b-66e0-445d-ba3e-1ccd5218133f | 2024-08-27 | Warnings, Adverse reactions | LEUPROLIDE ACETATE |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85882 | SUPPL | 2026-05-12 |
| 85845 | SUPPL | 2026-05-08 |
| 83625 | SUPPL | 2025-10-02 |
| 83621 | SUPPL | 2025-10-01 |
| 83589 | SUPPL | 2025-09-30 |
| 83475 | SUPPL | 2025-09-25 |
| 57626 | ORIG | 2019-02-15 |
| 57141 | SUPPL | 2019-01-09 |
| 56830 | SUPPL | 2018-12-20 |
| 53721 | SUPPL | 2018-04-18 |
| 48984 | SUPPL | 2017-07-14 |
| 48954 | SUPPL | 2017-07-12 |
| 48497 | SUPPL | 2017-05-23 |
| 48467 | SUPPL | 2017-05-19 |
| 48466 | SUPPL | 2017-05-19 |
| 11413 | SUPPL | 2014-07-11 |
| 1200 | SUPPL | 2014-07-11 |
| 23546 | ORIG | 2011-12-20 |
| 1199 | SUPPL | 2011-03-24 |
| 11412 | SUPPL | 2011-03-21 |
| 33686 | SUPPL | 2011-01-20 |
| 16168 | SUPPL | 2011-01-20 |
| 11411 | SUPPL | 2010-05-07 |
| 1198 | SUPPL | 2010-05-04 |
| 1197 | SUPPL | 2007-09-25 |
| 40859 | SUPPL | 2007-07-09 |
| 40858 | SUPPL | 2007-07-09 |
| 20196 | SUPPL | 2007-07-09 |
| 20195 | SUPPL | 2007-07-09 |
| 1196 | SUPPL | 2005-10-20 |
| 1195 | SUPPL | 2004-10-22 |
| 1194 | SUPPL | 2003-12-02 |