Application 022504
- Type
- NDA
- Sponsor
- ELI LILLY AND CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AXIRON | TESTOSTERONE | SOLUTION, METERED;TRANSDERMAL | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N022504-001 | AXIRON | TESTOSTERONE | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022504-001 | 8993520 | 2026-06-02 | U-1390 | 2015-04-09 | |
| N022504-001 | 9180194 | 2026-06-02 | U-1390 | 2015-12-03 | |
| N022504-001 | 8419307 | 2027-02-26 | U-1386 | 2013-04-30 | |
| N022504-001 | 8807861 | 2027-02-26 | U-1563 | Drug product | 2014-09-10 |
| N022504-001 | 9289586 | 2027-02-26 | U-1390 | 2016-04-19 | |
| N022504-001 | 8435944 | 2027-09-27 | U-1390 |
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 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N022504-001 | AXIRON | 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED / TRANSDERMAL | RLD | 2010-11-23 | f41ea6bd6efb… |
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 | N022504-001 | 8993520 | 2026-06-02 | U-1390 | 2015-04-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022504-001 | 9180194 | 2026-06-02 | U-1390 | 2015-12-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022504-001 | 8419307 | 2027-02-26 | U-1386 | 2013-04-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022504-001 | 8807861 | 2027-02-26 | U-1563 | Drug product | 2014-09-10 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022504-001 | 9289586 | 2027-02-26 | U-1390 | 2016-04-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022504-001 | 8435944 | 2027-09-27 | U-1390 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022504-001 | 8993520 | 2026-06-02 | U-1390 | 2015-04-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022504-001 | 9180194 | 2026-06-02 | U-1390 | 2015-12-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022504-001 | 8419307 | 2027-02-26 | U-1386 | 2013-04-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022504-001 | 8807861 | 2027-02-26 | U-1563 | Drug product | 2014-09-10 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022504-001 | 9289586 | 2027-02-26 | U-1390 | 2016-04-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022504-001 | 8435944 | 2027-09-27 | U-1390 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022504-001 | 8993520 | 2026-06-02 | U-1390 | 2015-04-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022504-001 | 9180194 | 2026-06-02 | U-1390 | 2015-12-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022504-001 | 8419307 | 2027-02-26 | U-1386 | 2013-04-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022504-001 | 8807861 | 2027-02-26 | U-1563 | Drug product | 2014-09-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022504-001 | 9289586 | 2027-02-26 | U-1390 | 2016-04-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022504-001 | 8435944 | 2027-09-27 | U-1390 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022504-001 | 8993520 | 2026-06-02 | U-1390 | 2015-04-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022504-001 | 9180194 | 2026-06-02 | U-1390 | 2015-12-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022504-001 | 8419307 | 2027-02-26 | U-1386 | 2013-04-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022504-001 | 8807861 | 2027-02-26 | U-1563 | Drug product | 2014-09-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022504-001 | 9289586 | 2027-02-26 | U-1390 | 2016-04-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022504-001 | 8435944 | 2027-09-27 | U-1390 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022504-001 | 8993520 | 2026-06-02 | U-1390 | 2015-04-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022504-001 | 9180194 | 2026-06-02 | U-1390 | 2015-12-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022504-001 | 8419307 | 2027-02-26 | U-1386 | 2013-04-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022504-001 | 8807861 | 2027-02-26 | U-1563 | Drug product | 2014-09-10 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022504-001 | 9289586 | 2027-02-26 | U-1390 | 2016-04-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022504-001 | 8435944 | 2027-09-27 | U-1390 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022504-001 | 8993520 | 2026-06-02 | U-1390 | 2015-04-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022504-001 | 9180194 | 2026-06-02 | U-1390 | 2015-12-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022504-001 | 8419307 | 2027-02-26 | U-1386 | 2013-04-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022504-001 | 8807861 | 2027-02-26 | U-1563 | Drug product | 2014-09-10 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022504-001 | 9289586 | 2027-02-26 | U-1390 | 2016-04-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022504-001 | 8435944 | 2027-09-27 | U-1390 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022504-001 | 8993520 | 2026-06-02 | U-1390 | 2015-04-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022504-001 | 9180194 | 2026-06-02 | U-1390 | 2015-12-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022504-001 | 8419307 | 2027-02-26 | U-1386 | 2013-04-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022504-001 | 8807861 | 2027-02-26 | U-1563 | Drug product | 2014-09-10 | b8a1b40f171c… |
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 |
|---|---|---|---|---|---|---|
| Testosterone | TESTOSTERONE | Encube Ethicals, Inc. | ca5d4865-356b-45e7-b603-fe299e450abc | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| TESTOSTERONE | TESTOSTERONE | Encube Ethicals, Inc. | 44a04f66-fd2a-45c7-934e-8f14c023ce14 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Northstar Rx LLC | 65981b8a-d5cc-1964-7eac-a07f032c2571 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Xiromed, LLC | 28e8d504-5073-1d78-f351-bcb7c5188ee6 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Lupin Pharmaceuticals, Inc. | 29c8846f-121c-4958-9e03-3bd271c21558 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Lupin Pharmaceuticals, Inc. | 61387416-510d-40c5-9e2d-24bfb7f56d08 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Bryant Ranch Prepack | c6c0a39e-0e75-4356-a052-c26c30c76b26 | 2025-11-04 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Actavis Pharma, Inc. | 5834d34f-839d-412c-b74c-da1dad2cfa88 | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Actavis Pharma, Inc. | e18b4495-c5a3-4a7f-9636-179320784381 | 2025-09-29 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Bryant Ranch Prepack | 6c7d2dec-6492-4d53-b110-61ffeae9ee61 | 2025-09-03 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| testosterone | TESTOSTERONE | Northstar Rx LLC | 2d55b825-8eab-4091-bdf2-9c52d111b8eb | 2025-08-31 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| testosterone | TESTOSTERONE | Padagis Israel Pharmaceuticals Ltd | 54fcdcb9-fb0e-4164-9e51-f2a5feae3217 | 2025-08-31 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Strides Pharma Science Limited | ee54c393-bcfe-4a52-b7b3-1da8750f35d9 | 2025-08-22 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Testosterone | TESTOSTERONE | Actavis Pharma, Inc. | 4f3c2c0a-7dab-4b50-9cae-869c3c2a8498 | 2025-08-01 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| testosterone | TESTOSTERONE | Bryant Ranch Prepack | 9e10a37a-9c40-456b-a362-2fa8eae31e84 | 2025-07-29 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Natesto nasal gel | TESTOSTERONE | Acerus Pharmaceuticals Corporation | dea6bed1-eaca-11e3-ac10-0800200c9a66 | 2025-07-22 | Warnings, Adverse reactions | TESTOSTERONE |
| Testopel | TESTOSTERONE | Endo USA, Inc. | 03b9c0b1-5884-11e4-8ed6-0800200c9a66 | 2025-07-17 | Warnings, Adverse reactions | TESTOSTERONE |
| Testim | TESTOSTERONE | Endo USA, Inc. | 9f2aae1f-898d-4955-be31-678e0cf85395 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| Vogelxo | TESTOSTERONE | Upsher-Smith Laboratories, LLC | 2dd150f6-cdfd-4d51-8888-12b288f26262 | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
| TESTOSTERONE | TESTOSTERONE | Alembic Pharmaceuticals Inc. | e39289aa-681c-47ec-9461-52e7f17e5d71 | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 48988 | SUPPL | 2017-07-14 |
| 48982 | SUPPL | 2017-07-14 |
| 48981 | SUPPL | 2017-07-14 |
| 47127 | SUPPL | 2017-02-07 |
| 47100 | SUPPL | 2017-02-06 |
| 46988 | SUPPL | 2017-01-27 |
| 45744 | SUPPL | 2016-11-01 |
| 45678 | SUPPL | 2016-10-27 |
| 29792 | SUPPL | 2015-05-13 |
| 17653 | SUPPL | 2015-05-13 |
| 42542 | SUPPL | 2014-07-07 |
| 38770 | SUPPL | 2014-06-23 |
| 7465 | SUPPL | 2014-06-23 |
| 29791 | SUPPL | 2011-12-28 |
| 17652 | SUPPL | 2011-12-23 |
| 44763 | ORIG | 2011-09-16 |
| 22038 | ORIG | 2011-09-16 |
| 44506 | ORIG | 2011-04-04 |
| 29790 | SUPPL | 2011-04-04 |
| 17651 | SUPPL | 2011-04-01 |
| 29789 | ORIG | 2010-11-29 |
| 38769 | ORIG | 2010-11-23 |