Application 209836
- Type
- ANDA
- Sponsor
- TWI PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TESTOSTERONE | TESTOSTERONE | SOLUTION, METERED;TRANSDERMAL | 30MG/1.5ML ACTUATION | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209836-001 | TESTOSTERONE | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | 2021-09-03 |
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 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | 2021-09-03 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | 2021-09-03 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | 2021-09-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | 2021-09-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | 2021-09-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | 782e0a99824c… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | AT | 2021-09-03 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209836-001 | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED / TRANSDERMAL | 2021-09-03 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209836-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209836-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209836-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209836-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209836-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209836-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209836-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209836-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209836-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209836-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A209836-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209836-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A209836-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A209836-001 | AT | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A209836-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A209836-001 | AT | 1 | 782e0a99824c… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209836-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A209836-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A209836-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209836-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209836-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209836-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209836-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A209836-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A209836-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209836-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A209836-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A209836-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A209836-001 | AT | 1 | 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 |
|---|---|---|---|---|---|---|
| Testosterone | TESTOSTERONE | Encube Ethicals, Inc. | ca5d4865-356b-45e7-b603-fe299e450abc | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | Testosterone TESTOSTERONE |
| TESTOSTERONE | TESTOSTERONE | Encube Ethicals, Inc. | 44a04f66-fd2a-45c7-934e-8f14c023ce14 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE TESTOSTERONE |
| Testosterone | TESTOSTERONE | Northstar Rx LLC | 65981b8a-d5cc-1964-7eac-a07f032c2571 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | Testosterone TESTOSTERONE |
| Testosterone | TESTOSTERONE | Xiromed, LLC | 28e8d504-5073-1d78-f351-bcb7c5188ee6 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | Testosterone TESTOSTERONE |
| Testosterone | TESTOSTERONE | Lupin Pharmaceuticals, Inc. | 29c8846f-121c-4958-9e03-3bd271c21558 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | Testosterone TESTOSTERONE |
| Testosterone | TESTOSTERONE | Lupin Pharmaceuticals, Inc. | 61387416-510d-40c5-9e2d-24bfb7f56d08 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | Testosterone TESTOSTERONE |
| Testosterone | TESTOSTERONE | Bryant Ranch Prepack | c6c0a39e-0e75-4356-a052-c26c30c76b26 | 2025-11-04 | Boxed warning, Warnings, Adverse reactions | Testosterone TESTOSTERONE |
| Testosterone | TESTOSTERONE | Actavis Pharma, Inc. | 5834d34f-839d-412c-b74c-da1dad2cfa88 | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | Testosterone TESTOSTERONE |
| Testosterone | TESTOSTERONE | Actavis Pharma, Inc. | e18b4495-c5a3-4a7f-9636-179320784381 | 2025-09-29 | Boxed warning, Warnings, Adverse reactions | Testosterone TESTOSTERONE |
| Testosterone | TESTOSTERONE | Bryant Ranch Prepack | 6c7d2dec-6492-4d53-b110-61ffeae9ee61 | 2025-09-03 | Boxed warning, Warnings, Adverse reactions | Testosterone TESTOSTERONE |
| testosterone | TESTOSTERONE | Northstar Rx LLC | 2d55b825-8eab-4091-bdf2-9c52d111b8eb | 2025-08-31 | Boxed warning, Warnings, Adverse reactions | testosterone TESTOSTERONE |
| testosterone | TESTOSTERONE | Padagis Israel Pharmaceuticals Ltd | 54fcdcb9-fb0e-4164-9e51-f2a5feae3217 | 2025-08-31 | Boxed warning, Warnings, Adverse reactions | testosterone TESTOSTERONE |
| Testosterone | TESTOSTERONE | Strides Pharma Science Limited | ee54c393-bcfe-4a52-b7b3-1da8750f35d9 | 2025-08-22 | Boxed warning, Warnings, Adverse reactions | Testosterone TESTOSTERONE |
| Testosterone | TESTOSTERONE | Actavis Pharma, Inc. | 4f3c2c0a-7dab-4b50-9cae-869c3c2a8498 | 2025-08-01 | Boxed warning, Warnings, Adverse reactions | Testosterone TESTOSTERONE |
| testosterone | TESTOSTERONE | Bryant Ranch Prepack | 9e10a37a-9c40-456b-a362-2fa8eae31e84 | 2025-07-29 | Boxed warning, Warnings, Adverse reactions | testosterone 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 TESTOSTERONE |