Application 020263
- Type
- NDA
- Sponsor
- ABBVIE ENDOCRINE INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | LUPRON DEPOT-PED | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 7.5MG/VIAL | Yes | Yes |
| 003 | LUPRON DEPOT-PED | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 3.75MG/VIAL,7.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | LUPRON DEPOT-PED | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 7.5MG/VIAL,7.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | LUPRON DEPOT-PED | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 11.25MG/VIAL | Yes | Yes |
| 006 | LUPRON DEPOT-PED | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 15MG/VIAL | Yes | Yes |
| 007 | LUPRON DEPOT-PED | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 11.25MG/VIAL | Yes | Yes |
| 008 | LUPRON DEPOT-PED | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 30MG/VIAL | Yes | Yes |
| 009 | LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | POWDER;INTRAMUSCULAR | 45MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020263-002 | LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | 7.5MG | POWDER / INTRAMUSCULAR | RLD, RS | 1993-04-16 | |
| N020263-003 | LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER / INTRAMUSCULAR | RLD | 1993-04-16 | |
| N020263-004 | LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER / INTRAMUSCULAR | RLD | 1993-04-16 | |
| N020263-005 | LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | 11.25MG | POWDER / INTRAMUSCULAR | RLD, RS | 1994-01-21 | |
| N020263-006 | LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | 15MG | POWDER / INTRAMUSCULAR | RLD, RS | 1994-01-21 | |
| N020263-007 | LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | 11.25MG | POWDER / INTRAMUSCULAR | RLD, RS | 2011-08-15 | |
| N020263-008 | LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | 30MG | POWDER / INTRAMUSCULAR | RLD, RS | 2011-08-15 | |
| N020263-009 | LUPRON DEPOT-PED KIT | LEUPROLIDE ACETATE | 45MG | POWDER / INTRAMUSCULAR | RLD, RS | 2023-04-14 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | |
| N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N020263-009 | NS | 2026-04-14 |
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 | N020263-002 | LUPRON DEPOT-PED KIT | 7.5MG | POWDER / INTRAMUSCULAR | RLD, RS | 1993-04-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020263-003 | LUPRON DEPOT-PED KIT | 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER / INTRAMUSCULAR | RLD | 1993-04-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020263-004 | LUPRON DEPOT-PED KIT | 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER / INTRAMUSCULAR | RLD | 1993-04-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020263-005 | LUPRON DEPOT-PED KIT | 11.25MG | POWDER / INTRAMUSCULAR | RLD, RS | 1994-01-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020263-006 | LUPRON DEPOT-PED KIT | 15MG | POWDER / INTRAMUSCULAR | RLD, RS | 1994-01-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020263-007 | LUPRON DEPOT-PED KIT | 11.25MG | POWDER / INTRAMUSCULAR | RLD, RS | 2011-08-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020263-008 | LUPRON DEPOT-PED KIT | 30MG | POWDER / INTRAMUSCULAR | RLD, RS | 2011-08-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020263-009 | LUPRON DEPOT-PED KIT | 45MG | POWDER / INTRAMUSCULAR | RLD, RS | 2023-04-14 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020263-002 | LUPRON DEPOT-PED KIT | 7.5MG | POWDER / INTRAMUSCULAR | RLD, RS | 1993-04-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020263-003 | LUPRON DEPOT-PED KIT | 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER / INTRAMUSCULAR | RLD | 1993-04-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020263-004 | LUPRON DEPOT-PED KIT | 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER / INTRAMUSCULAR | RLD | 1993-04-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020263-005 | LUPRON DEPOT-PED KIT | 11.25MG | POWDER / INTRAMUSCULAR | RLD, RS | 1994-01-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020263-006 | LUPRON DEPOT-PED KIT | 15MG | POWDER / INTRAMUSCULAR | RLD, RS | 1994-01-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020263-007 | LUPRON DEPOT-PED KIT | 11.25MG | POWDER / INTRAMUSCULAR | RLD, RS | 2011-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020263-008 | LUPRON DEPOT-PED KIT | 30MG | POWDER / INTRAMUSCULAR | RLD, RS | 2011-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020263-009 | LUPRON DEPOT-PED KIT | 45MG | POWDER / INTRAMUSCULAR | RLD, RS | 2023-04-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020263-002 | LUPRON DEPOT-PED KIT | 7.5MG | POWDER / INTRAMUSCULAR | RLD, RS | 1993-04-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020263-003 | LUPRON DEPOT-PED KIT | 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER / INTRAMUSCULAR | RLD | 1993-04-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020263-004 | LUPRON DEPOT-PED KIT | 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER / INTRAMUSCULAR | RLD | 1993-04-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020263-005 | LUPRON DEPOT-PED KIT | 11.25MG | POWDER / INTRAMUSCULAR | RLD, RS | 1994-01-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020263-006 | LUPRON DEPOT-PED KIT | 15MG | POWDER / INTRAMUSCULAR | RLD, RS | 1994-01-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020263-007 | LUPRON DEPOT-PED KIT | 11.25MG | POWDER / INTRAMUSCULAR | RLD, RS | 2011-08-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020263-008 | LUPRON DEPOT-PED KIT | 30MG | POWDER / INTRAMUSCULAR | RLD, RS | 2011-08-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020263-009 | LUPRON DEPOT-PED KIT | 45MG | POWDER / INTRAMUSCULAR | RLD, RS | 2023-04-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020263-002 | LUPRON DEPOT-PED KIT | 7.5MG | POWDER / INTRAMUSCULAR | RLD, RS | 1993-04-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020263-003 | LUPRON DEPOT-PED KIT | 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER / INTRAMUSCULAR | RLD | 1993-04-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020263-004 | LUPRON DEPOT-PED KIT | 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER / INTRAMUSCULAR | RLD | 1993-04-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020263-005 | LUPRON DEPOT-PED KIT | 11.25MG | POWDER / INTRAMUSCULAR | RLD, RS | 1994-01-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020263-006 | LUPRON DEPOT-PED KIT | 15MG | POWDER / INTRAMUSCULAR | RLD, RS | 1994-01-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020263-007 | LUPRON DEPOT-PED KIT | 11.25MG | POWDER / INTRAMUSCULAR | RLD, RS | 2011-08-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020263-008 | LUPRON DEPOT-PED KIT | 30MG | POWDER / INTRAMUSCULAR | RLD, RS | 2011-08-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020263-009 | LUPRON DEPOT-PED KIT | 45MG | POWDER / INTRAMUSCULAR | RLD, RS | 2023-04-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020263-002 | LUPRON DEPOT-PED KIT | 7.5MG | POWDER / INTRAMUSCULAR | RLD, RS | 1993-04-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020263-003 | LUPRON DEPOT-PED KIT | 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER / INTRAMUSCULAR | RLD | 1993-04-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020263-004 | LUPRON DEPOT-PED KIT | 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER / INTRAMUSCULAR | RLD | 1993-04-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020263-005 | LUPRON DEPOT-PED KIT | 11.25MG | POWDER / INTRAMUSCULAR | RLD, RS | 1994-01-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020263-006 | LUPRON DEPOT-PED KIT | 15MG | POWDER / INTRAMUSCULAR | RLD, RS | 1994-01-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020263-007 | LUPRON DEPOT-PED KIT | 11.25MG | POWDER / INTRAMUSCULAR | RLD, RS | 2011-08-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020263-008 | LUPRON DEPOT-PED KIT | 30MG | POWDER / INTRAMUSCULAR | RLD, RS | 2011-08-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020263-009 | LUPRON DEPOT-PED KIT | 45MG | POWDER / INTRAMUSCULAR | RLD, RS | 2023-04-14 | 6a471c1ec25d… |
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 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020263-009 | 9617303 | 2028-03-22 | U-3611 | 2023-05-12 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020263-009 | 8921326 | 2031-02-05 | Drug product | 2023-05-12 | a72a2bbeb626… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020263-009 | NS | 2026-04-14 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N020263-009 | NS | 2026-04-14 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020263-009 | NS | 2026-04-14 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020263-009 | NS | 2026-04-14 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020263-009 | NS | 2026-04-14 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020263-009 | NS | 2026-04-14 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020263-009 | NS | 2026-04-14 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020263-009 | NS | 2026-04-14 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020263-009 | NS | 2026-04-14 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020263-009 | NS | 2026-04-14 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020263-009 | NS | 2026-04-14 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020263-009 | NS | 2026-04-14 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020263-009 | NS | 2026-04-14 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020263-009 | NS | 2026-04-14 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020263-009 | NS | 2026-04-14 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020263-009 | NS | 2026-04-14 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020263-009 | NS | 2026-04-14 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N020263-009 | NS | 2026-04-14 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N020263-009 | NS | 2026-04-14 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020263-009 | NS | 2026-04-14 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020263-009 | NS | 2026-04-14 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020263-009 | NS | 2026-04-14 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020263-009 | NS | 2026-04-14 | 3f0d92c62455… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N020263-009 | NS | 2026-04-14 | a50c72e98297… |
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-PED | LEUPROLIDE ACETATE | AbbVie Inc. | e99f47d2-da10-3127-ecb3-e5d942ae6e81 | 2025-11-14 | Warnings, Adverse reactions | 020263 NDA020263 0074-3779 0074-2440 0074-2282 0074-2108 0074-9694 |
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 |
|---|---|---|---|---|---|
| 0074-2108 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2108 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2108 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2108 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2108 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2108 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2108 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2282 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2282 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2282 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2282 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2282 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2282 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2282 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2440 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2440 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2440 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2440 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2440 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2440 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-2440 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3779 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3779 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3779 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3779 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3779 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3779 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3779 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-9694 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-9694 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-9694 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-9694 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-9694 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-9694 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-9694 | Lupron Depot-PED | leuprolide acetate | AbbVie Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84181 | SUPPL | 2025-11-18 |
| 84174 | SUPPL | 2025-11-17 |
| 84173 | SUPPL | 2025-11-17 |
| 83457 | SUPPL | 2025-09-25 |
| 83424 | SUPPL | 2025-09-24 |
| 82447 | SUPPL | 2025-06-03 |
| 82331 | SUPPL | 2025-05-27 |
| 76735 | SUPPL | 2023-12-15 |
| 76732 | SUPPL | 2023-12-05 |
| 74008 | SUPPL | 2023-04-17 |
| 74001 | SUPPL | 2023-04-17 |
| 70827 | SUPPL | 2022-04-27 |
| 70826 | SUPPL | 2022-04-27 |
| 70808 | SUPPL | 2022-04-26 |
| 69307 | SUPPL | 2021-11-15 |
| 66768 | SUPPL | 2021-03-12 |
| 66767 | SUPPL | 2021-03-12 |
| 66766 | SUPPL | 2021-03-12 |
| 66765 | SUPPL | 2021-03-12 |
| 66763 | SUPPL | 2021-03-12 |
| 66762 | SUPPL | 2021-03-12 |
| 62615 | SUPPL | 2020-04-21 |
| 62614 | SUPPL | 2020-04-21 |
| 62479 | SUPPL | 2020-04-08 |
| 53722 | SUPPL | 2018-04-18 |
| 48494 | SUPPL | 2017-05-23 |
| 48476 | SUPPL | 2017-05-22 |
| 48475 | SUPPL | 2017-05-22 |
| 34452 | SUPPL | 2013-05-21 |
| 2268 | SUPPL | 2013-05-16 |
| 44052 | ORIG | 2011-12-20 |
| 34451 | SUPPL | 2011-10-12 |
| 24693 | SUPPL | 2011-10-12 |
| 24692 | SUPPL | 2011-08-17 |
| 34450 | SUPPL | 2011-08-15 |
| 24691 | SUPPL | 2010-09-02 |
| 34449 | SUPPL | 2010-08-30 |
| 24690 | SUPPL | 2009-06-30 |
| 12394 | SUPPL | 2009-06-29 |
| 2267 | SUPPL | 2008-08-05 |
| 41253 | SUPPL | 2007-07-09 |
| 41252 | SUPPL | 2007-07-09 |
| 41251 | SUPPL | 2007-07-09 |
| 20576 | SUPPL | 2007-07-09 |
| 34448 | SUPPL | 2006-02-22 |
| 2266 | SUPPL | 2006-02-22 |
| 24689 | SUPPL | 2005-11-18 |
| 12393 | SUPPL | 2005-11-17 |
| 12392 | SUPPL | 2004-04-05 |
| 24688 | SUPPL | 2004-03-10 |
| 24687 | SUPPL | 2003-12-24 |
| 24686 | SUPPL | 2003-10-31 |
| 2265 | SUPPL | 2002-09-24 |