Application 210609
- Type
- ANDA
- Sponsor
- PRINSTON INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TADALAFIL | TADALAFIL | TABLET;ORAL | 2.5MG | No | No |
| 002 | TADALAFIL | TADALAFIL | TABLET;ORAL | 5MG | No | No |
| 003 | TADALAFIL | TADALAFIL | TABLET;ORAL | 10MG | No | No |
| 004 | TADALAFIL | TADALAFIL | TABLET;ORAL | 20MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210609-001 | TADALAFIL | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2022-08-11 | |
| A210609-002 | TADALAFIL | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2022-08-11 | |
| A210609-003 | TADALAFIL | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2022-08-11 | |
| A210609-004 | TADALAFIL | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2022-08-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210609-001 | AB1 |
| A210609-002 | AB1 |
| A210609-003 | AB1 |
| A210609-004 | AB1 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A210609-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2022-08-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210609-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2022-08-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210609-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2022-08-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210609-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2022-08-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210609-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2022-08-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210609-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2022-08-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210609-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2022-08-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210609-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2022-08-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210609-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2022-08-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210609-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2022-08-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210609-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2022-08-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210609-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2022-08-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210609-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2022-08-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210609-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2022-08-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210609-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2022-08-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210609-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2022-08-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210609-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2022-08-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210609-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2022-08-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210609-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2022-08-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210609-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2022-08-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210609-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2022-08-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210609-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2022-08-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210609-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2022-08-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210609-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2022-08-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210609-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2022-08-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210609-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2022-08-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210609-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2022-08-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210609-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2022-08-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210609-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2022-08-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210609-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2022-08-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210609-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2022-08-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210609-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2022-08-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210609-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2022-08-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210609-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2022-08-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210609-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2022-08-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210609-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2022-08-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210609-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2022-08-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210609-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2022-08-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210609-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2022-08-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210609-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2022-08-11 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A210609-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210609-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210609-003 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210609-004 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A210609-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210609-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210609-003 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210609-004 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210609-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210609-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210609-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210609-004 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210609-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210609-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210609-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210609-004 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210609-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210609-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210609-003 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210609-004 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210609-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210609-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210609-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210609-004 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210609-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210609-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210609-003 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210609-004 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210609-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210609-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210609-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210609-004 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210609-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210609-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210609-003 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210609-004 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210609-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210609-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210609-003 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210609-004 | AB1 | 1 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|---|
| TADALAFIL | TADALAFIL | REMEDYREPACK INC. | 89a33a41-0f01-4f29-8b2f-769d649fbdcb | 2026-06-10 | Warnings, Adverse reactions | 210609 ANDA210609 |
| TADALAFIL | TADALAFIL | Bryant Ranch Prepack | b3a58c17-f260-4125-abd1-27da00bb0719 | 2026-05-29 | Warnings, Adverse reactions | 210609 ANDA210609 |
| TADALAFIL | TADALAFIL | NuCare Pharmaceuticals,Inc.. | 16f13179-7c87-aa6c-e063-6294a90a93eb | 2026-05-19 | Warnings, Adverse reactions | 210609 ANDA210609 |
| TADALAFIL | TADALAFIL | Aphena Pharma Solutions - Tennessee, LLC | 351e28ca-3ae6-e535-e063-6394a90a9fb7 | 2026-03-23 | Warnings, Adverse reactions | 210609 ANDA210609 |
| TADALAFIL | TADALAFIL | A-S Medication Solutions | cd94158b-43fa-44fc-a858-0983770efa83 | 2026-02-02 | Warnings, Adverse reactions | 210609 ANDA210609 |
| TADALAFIL | TADALAFIL | Preferred Pharmaceuticals Inc. | 66e24ced-0008-40cb-b242-9d9add1f665c | 2025-09-25 | Warnings, Adverse reactions | 210609 ANDA210609 |
| TADALAFIL | TADALAFIL | Preferred Pharmaceuticals Inc. | 09ad27a1-3908-4533-b84c-7a7fd3514101 | 2025-09-25 | Warnings, Adverse reactions | 210609 ANDA210609 |
| TADALAFIL | TADALAFIL | Solco Healthcare US, LLC | 05640a4d-afb7-42ae-a5bb-77dbc8412356 | 2025-08-31 | Warnings, Adverse reactions | 210609 ANDA210609 43547-050 43547-049 43547-051 43547-047 |
| TADALAFIL | TADALAFIL | Bryant Ranch Prepack | 716c586d-e524-4f3e-ab1d-7ef9184169d9 | 2025-06-02 | Warnings, Adverse reactions | 210609 ANDA210609 |
| TADALAFIL | TADALAFIL | Aphena Pharma Solutions - Tennessee, LLC | 351de7c2-98bf-7c88-e063-6294a90ad811 | 2025-05-21 | Warnings, Adverse reactions | 210609 ANDA210609 |
| TADALAFIL | TADALAFIL | Aphena Pharma Solutions - Tennessee, LLC | 34684fe8-9bf3-47fd-e063-6394a90ac80f | 2025-05-14 | Warnings, Adverse reactions | 210609 ANDA210609 |
| TADALAFIL | TADALAFIL | NuCare Pharmaceuticals, Inc. | 2c4108c6-9014-4bd8-e063-6294a90a88fa | 2025-04-09 | Warnings, Adverse reactions | 210609 ANDA210609 |
| TADALAFIL | TADALAFIL | Solco Healthcare US, LLC | 491cb72b-71f2-4df9-99f8-c02d93500103 | 2025-03-31 | Warnings, Adverse reactions | 210609 ANDA210609 |
| TADALAFIL | TADALAFIL | NuCare Pharmaceuticals, Inc. | 2eae8756-5c7f-2545-e063-6294a90a6d52 | 2025-02-21 | Warnings, Adverse reactions | 210609 ANDA210609 |
| TADALAFIL | TADALAFIL | NuCare Pharmaceuticals,Inc. | 0b75f746-866e-3a5b-e063-6294a90a5e02 | 2025-01-03 | Warnings, Adverse reactions | 210609 ANDA210609 |
| TADALAFIL | TADALAFIL | NuCare Pharmaceuticals, Inc. | 2ad52dff-9fcd-041f-e063-6394a90afcef | 2025-01-03 | Warnings, Adverse reactions | 210609 ANDA210609 |
| TADALAFIL | TADALAFIL | NuCare Pharmaceuticals,Inc. | 2a4666e1-4151-f540-e063-6394a90aed0b | 2024-12-27 | Warnings, Adverse reactions | 210609 ANDA210609 |
| TADALAFIL | TADALAFIL | NuCare Pharmaceuticals,Inc. | 17947ccd-6f0e-d4cd-e063-6294a90a108a | 2024-05-03 | Warnings, Adverse reactions | 210609 ANDA210609 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43547-047 | TADALAFIL | tadalafil | Solco Healthcare US, LLC | ANDA | Current |
| 43547-049 | TADALAFIL | tadalafil | Solco Healthcare US, LLC | ANDA | Current |
| 43547-050 | TADALAFIL | tadalafil | Solco Healthcare US, LLC | ANDA | Current |
| 43547-051 | TADALAFIL | tadalafil | Solco Healthcare US, LLC | ANDA | Current |