Application 020517
- Type
- NDA
- Sponsor
- ABBVIE ENDOCRINE INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LUPRON DEPOT | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 22.5MG/VIAL | Yes | No |
| 002 | LUPRON DEPOT | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 30MG/VIAL | Yes | Yes |
| 003 | LUPRON DEPOT | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 45MG/VIAL | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020517-001 | LUPRON DEPOT | LEUPROLIDE ACETATE | 22.5MG | INJECTABLE / INJECTION | RLD | 1995-12-22 | |
| N020517-002 | LUPRON DEPOT | LEUPROLIDE ACETATE | 30MG | INJECTABLE / INJECTION | RLD, RS | 1997-05-30 | |
| N020517-003 | LUPRON DEPOT | LEUPROLIDE ACETATE | 45MG | INJECTABLE / INJECTION | RLD, RS | 2011-06-17 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N020517-003 | 9617303 | 2028-03-22 | U-4001 | 2024-10-04 | |
| N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020517-001 | LUPRON DEPOT | 22.5MG | INJECTABLE / INJECTION | RLD | 1995-12-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020517-002 | LUPRON DEPOT | 30MG | INJECTABLE / INJECTION | RLD, RS | 1997-05-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020517-003 | LUPRON DEPOT | 45MG | INJECTABLE / INJECTION | RLD, RS | 2011-06-17 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020517-001 | LUPRON DEPOT | 22.5MG | INJECTABLE / INJECTION | RLD | 1995-12-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020517-002 | LUPRON DEPOT | 30MG | INJECTABLE / INJECTION | RLD, RS | 1997-05-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020517-003 | LUPRON DEPOT | 45MG | INJECTABLE / INJECTION | RLD, RS | 2011-06-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020517-001 | LUPRON DEPOT | 22.5MG | INJECTABLE / INJECTION | RLD | 1995-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020517-002 | LUPRON DEPOT | 30MG | INJECTABLE / INJECTION | RLD, RS | 1997-05-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020517-003 | LUPRON DEPOT | 45MG | INJECTABLE / INJECTION | RLD, RS | 2011-06-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020517-001 | LUPRON DEPOT | 22.5MG | INJECTABLE / INJECTION | RLD | 1995-12-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020517-002 | LUPRON DEPOT | 30MG | INJECTABLE / INJECTION | RLD, RS | 1997-05-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020517-003 | LUPRON DEPOT | 45MG | INJECTABLE / INJECTION | RLD, RS | 2011-06-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020517-001 | LUPRON DEPOT | 22.5MG | INJECTABLE / INJECTION | RLD | 1995-12-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020517-002 | LUPRON DEPOT | 30MG | INJECTABLE / INJECTION | RLD, RS | 1997-05-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020517-003 | LUPRON DEPOT | 45MG | INJECTABLE / INJECTION | RLD, RS | 2011-06-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020517-001 | LUPRON DEPOT | 22.5MG | INJECTABLE / INJECTION | RLD | 1995-12-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020517-002 | LUPRON DEPOT | 30MG | INJECTABLE / INJECTION | RLD, RS | 1997-05-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020517-003 | LUPRON DEPOT | 45MG | INJECTABLE / INJECTION | RLD, RS | 2011-06-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020517-001 | LUPRON DEPOT | 22.5MG | INJECTABLE / INJECTION | RLD | 1995-12-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020517-002 | LUPRON DEPOT | 30MG | INJECTABLE / INJECTION | RLD, RS | 1997-05-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020517-003 | LUPRON DEPOT | 45MG | INJECTABLE / INJECTION | RLD, RS | 2011-06-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020517-001 | LUPRON DEPOT | 22.5MG | INJECTABLE / INJECTION | RLD | 1995-12-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020517-002 | LUPRON DEPOT | 30MG | INJECTABLE / INJECTION | RLD, RS | 1997-05-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020517-003 | LUPRON DEPOT | 45MG | INJECTABLE / INJECTION | RLD, RS | 2011-06-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020517-001 | LUPRON DEPOT | 22.5MG | INJECTABLE / INJECTION | RLD | 1995-12-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020517-002 | LUPRON DEPOT | 30MG | INJECTABLE / INJECTION | RLD, RS | 1997-05-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020517-003 | LUPRON DEPOT | 45MG | INJECTABLE / INJECTION | RLD, RS | 2011-06-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020517-001 | LUPRON DEPOT | 22.5MG | INJECTABLE / INJECTION | RLD | 1995-12-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020517-002 | LUPRON DEPOT | 30MG | INJECTABLE / INJECTION | RLD, RS | 1997-05-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020517-003 | LUPRON DEPOT | 45MG | INJECTABLE / INJECTION | RLD, RS | 2011-06-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020517-001 | LUPRON DEPOT | 22.5MG | INJECTABLE / INJECTION | RLD | 1995-12-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020517-002 | LUPRON DEPOT | 30MG | INJECTABLE / INJECTION | RLD, RS | 1997-05-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020517-003 | LUPRON DEPOT | 45MG | INJECTABLE / INJECTION | RLD, RS | 2011-06-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020517-001 | LUPRON DEPOT | 22.5MG | INJECTABLE / INJECTION | RLD | 1995-12-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020517-002 | LUPRON DEPOT | 30MG | INJECTABLE / INJECTION | RLD, RS | 1997-05-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020517-003 | LUPRON DEPOT | 45MG | INJECTABLE / INJECTION | RLD, RS | 2011-06-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020517-001 | LUPRON DEPOT | 22.5MG | INJECTABLE / INJECTION | RLD | 1995-12-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020517-002 | LUPRON DEPOT | 30MG | INJECTABLE / INJECTION | RLD, RS | 1997-05-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020517-003 | LUPRON DEPOT | 45MG | INJECTABLE / INJECTION | RLD, RS | 2011-06-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020517-001 | LUPRON DEPOT | 22.5MG | INJECTABLE / INJECTION | RLD | 1995-12-22 | 301d65b070ca… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020517-003 | 9617303 | 2028-03-22 | U-4001 | 2024-10-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N020517-003 | 9617303 | 2028-03-22 | U-4001 | 2024-10-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020517-003 | 9617303 | 2028-03-22 | U-4001 | 2024-10-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020517-003 | 9617303 | 2028-03-22 | U-4001 | 2024-10-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020517-003 | 9617303 | 2028-03-22 | U-4001 | 2024-10-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020517-003 | 9617303 | 2028-03-22 | U-4001 | 2024-10-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020517-003 | 9617303 | 2028-03-22 | U-4001 | 2024-10-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020517-003 | 9617303 | 2028-03-22 | U-4001 | 2024-10-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020517-003 | 9617303 | 2028-03-22 | U-4001 | 2024-10-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020517-003 | 9617303 | 2028-03-22 | U-4001 | 2024-10-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020517-003 | 9617303 | 2028-03-22 | U-4001 | 2024-10-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020517-003 | 8815801 | 2022-06-28 | Drug product | 2015-03-13 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020517-003 | 8815801 | 2022-06-28 | Drug product | 2015-03-13 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020517-003 | 8815801 | 2022-06-28 | Drug product | 2015-03-13 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020517-003 | 7429559 | 2019-01-13 | Drug product | 2011-07-13 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020517-003 | 8815801 | 2022-06-28 | Drug product | 2015-03-13 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020517-003 | 8815801 | 2022-06-28 | Drug product | 2015-03-13 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020517-003 | 8815801 | 2022-06-28 | Drug product | 2015-03-13 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020517-003 | 8921326 | 2031-02-05 | U-1666 | Drug product | 2015-03-13 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| Lupron Depot | LEUPROLIDE ACETATE | AbbVie Inc. | cbc8f94e-7330-4465-05ad-16d64493a5dd | 2026-03-15 | Warnings, Adverse reactions | 020517 NDA020517 0074-3683 0074-3473 0074-3346 |
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 |
|---|---|---|---|---|---|
| 0074-3346 | Lupron Depot | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3346 | Lupron Depot | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3346 | Lupron Depot | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3346 | Lupron Depot | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3346 | Lupron Depot | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3473 | Lupron Depot | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3473 | Lupron Depot | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3473 | Lupron Depot | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3473 | Lupron Depot | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3473 | Lupron Depot | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3683 | Lupron Depot | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3683 | Lupron Depot | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3683 | Lupron Depot | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3683 | Lupron Depot | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3683 | Lupron Depot | leuprolide acetate | AbbVie Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83147 | SUPPL | 2025-08-20 |
| 83133 | SUPPL | 2025-08-19 |
| 77927 | SUPPL | 2024-03-25 |
| 77917 | SUPPL | 2024-03-22 |
| 76734 | SUPPL | 2023-12-05 |
| 76730 | SUPPL | 2023-12-05 |
| 70794 | SUPPL | 2022-04-20 |
| 70791 | SUPPL | 2022-04-19 |
| 57914 | SUPPL | 2019-03-07 |
| 57892 | SUPPL | 2019-03-05 |
| 57143 | SUPPL | 2019-01-09 |
| 56833 | SUPPL | 2018-12-20 |
| 12671 | SUPPL | 2016-06-13 |
| 25091 | SUPPL | 2016-06-08 |
| 41409 | SUPPL | 2015-01-20 |
| 41408 | SUPPL | 2015-01-20 |
| 20695 | SUPPL | 2015-01-20 |
| 34747 | SUPPL | 2014-07-01 |
| 25090 | SUPPL | 2014-07-01 |
| 2649 | SUPPL | 2013-07-12 |
| 12670 | SUPPL | 2013-07-11 |
| 2648 | SUPPL | 2012-07-20 |
| 12669 | SUPPL | 2012-07-19 |
| 23581 | ORIG | 2011-12-20 |
| 25087 | SUPPL | 2011-06-29 |
| 2647 | SUPPL | 2011-06-29 |
| 2646 | SUPPL | 2011-06-29 |
| 34746 | SUPPL | 2011-06-28 |
| 34744 | SUPPL | 2011-06-28 |
| 12668 | SUPPL | 2011-06-28 |
| 25089 | SUPPL | 2011-01-20 |
| 12667 | SUPPL | 2011-01-20 |
| 34745 | SUPPL | 2010-05-07 |
| 12666 | SUPPL | 2010-05-07 |
| 12665 | SUPPL | 2010-05-07 |
| 25088 | SUPPL | 2010-05-04 |
| 25086 | SUPPL | 2010-05-04 |
| 2645 | SUPPL | 2010-05-04 |
| 41407 | SUPPL | 2007-07-09 |
| 41406 | SUPPL | 2007-07-09 |
| 20694 | SUPPL | 2007-07-09 |
| 20692 | ORIG | 2006-04-06 |
| 41405 | SUPPL | 2006-03-30 |
| 25085 | SUPPL | 2005-10-20 |
| 2644 | SUPPL | 2005-10-20 |
| 2643 | SUPPL | 2004-01-14 |
| 25084 | SUPPL | 2003-09-25 |
| 20693 | SUPPL | 1997-05-30 |