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 | Amneal Pharmaceuticals NY LLC | f9888b14-67f4-4c87-8f7b-d51baef9891b | 2025-07-12 | Boxed warning, Warnings, Adverse reactions | Testosterone TESTOSTERONE |
| Testosterone | TESTOSTERONE | Upsher-Smith Laboratories, LLC | a887020f-b41f-49fe-8379-f01147b2a796 | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | Testosterone TESTOSTERONE |
| testosterone | TESTOSTERONE | Padagis Israel Pharmaceuticals Ltd | c0c56607-e995-4bed-9c62-e33a722b38b5 | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | testosterone TESTOSTERONE |
| testosterone | TESTOSTERONE | Bryant Ranch Prepack | 78384754-5883-46b1-84e7-c063b4b4be82 | 2025-06-26 | Boxed warning, Warnings, Adverse reactions | testosterone TESTOSTERONE |
| Testosterone | TESTOSTERONE | Upsher-Smith Laboratories, LLC | 10dab294-6a43-4bb3-9d91-2d200c624ffb | 2025-06-10 | Warnings, Adverse reactions | Testosterone TESTOSTERONE |
| Testosterone | TESTOSTERONE | Cipla USA Inc. | 6a46b5de-5d95-4570-91a6-3e4278028c59 | 2025-06-04 | Boxed warning, Warnings, Adverse reactions | Testosterone TESTOSTERONE |
| Testosterone | TESTOSTERONE | Actavis Pharma, Inc. | 7227ab2f-c8ef-4bab-92ab-3092182abcc9 | 2025-03-01 | Boxed warning, Warnings, Adverse reactions | Testosterone TESTOSTERONE |
| Testosterone | TESTOSTERONE | Zoe Processing | 0bb2581c-5a65-469b-8f9a-954ac9cc90fb | 2025-02-03 | Warnings | Testosterone TESTOSTERONE |
| Testosterone | TESTOSTERONE | Prasco Laboratories | 68b2375d-0365-4797-bc3d-63531c9f42fd | 2024-12-01 | Boxed warning, Warnings, Adverse reactions | Testosterone TESTOSTERONE |
| testosterone | TESTOSTERONE | Bryant Ranch Prepack | 5be74193-de73-436d-a9a1-35a857bc8e0c | 2024-10-22 | Boxed warning, Warnings, Adverse reactions | testosterone TESTOSTERONE |
| Testosterone | TESTOSTERONE | Prasco Laboratories | 0d84e5a6-11e9-4940-8991-21c611c4c32f | 2024-09-30 | Boxed warning, Warnings, Adverse reactions | Testosterone TESTOSTERONE |
| testosterone | TESTOSTERONE | Bryant Ranch Prepack | d22a072f-529b-4878-90fc-4365d9dc67e6 | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | testosterone TESTOSTERONE |
| Testosterone | TESTOSTERONE | Deseret Biologicals, Inc. | c16ddade-d47a-4296-8926-d19d9f671aa3 | 2024-02-27 | Warnings | Testosterone TESTOSTERONE |
| TESTOSTERONE | TESTOSTERONE | Alembic Pharmaceuticals Inc. | 21705fce-bc6c-41f6-aa92-fa6fc1c22fb6 | 2023-12-08 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE TESTOSTERONE |
| testosterone | TESTOSTERONE | Bryant Ranch Prepack | 86254445-efd1-46d9-8236-3a0d98316f28 | 2023-12-05 | Boxed warning, Warnings, Adverse reactions | testosterone TESTOSTERONE |
| Testosterone | TESTOSTERONE | Dr. Reddy's Laboratories, Inc. | ccadef00-3d5f-f926-e0fb-8dabe859f271 | 2019-05-21 | Boxed warning, Warnings, Adverse reactions | Testosterone TESTOSTERONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.