Application 209167
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
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 |
|---|---|---|---|---|---|---|---|
| A209167-001 | TADALAFIL | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | |
| A209167-002 | TADALAFIL | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | |
| A209167-003 | TADALAFIL | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-10-23 | |
| A209167-004 | TADALAFIL | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209167-001 | AB1 |
| A209167-002 | AB1 |
| A209167-003 | AB1 |
| A209167-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A209167-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209167-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209167-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-10-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209167-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A209167-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209167-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209167-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-10-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209167-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209167-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209167-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209167-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-10-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209167-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209167-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209167-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209167-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-10-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209167-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209167-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209167-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209167-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-10-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209167-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209167-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209167-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209167-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-10-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209167-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209167-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209167-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209167-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-10-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209167-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209167-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209167-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209167-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-10-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209167-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209167-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209167-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209167-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-10-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209167-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209167-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209167-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209167-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-10-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209167-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A209167-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209167-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209167-003 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209167-004 | AB1 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A209167-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209167-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209167-003 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209167-004 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A209167-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209167-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209167-003 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209167-004 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209167-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209167-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209167-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209167-004 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209167-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209167-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209167-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209167-004 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209167-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209167-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209167-003 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209167-004 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209167-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209167-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209167-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209167-004 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209167-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209167-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209167-003 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209167-004 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209167-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209167-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209167-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209167-004 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209167-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209167-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209167-003 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209167-004 | AB1 | 1 | 5bbf6a4d5a75… |
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 | A-S Medication Solutions | a6847ad6-3b5b-47e5-a3b5-04dc3182d72b | 2026-08-25 | Warnings, Adverse reactions | 209167 ANDA209167 50090-6150 |
| Tadalafil | TADALAFIL | Bryant Ranch Prepack | 07567ae5-7345-4ab1-9b2c-c586c4da0427 | 2026-06-24 | Warnings, Adverse reactions | 209167 ANDA209167 63629-8409 |
| Tadalafil | TADALAFIL | Bryant Ranch Prepack | aa8d165b-0c7d-497a-b56a-7c62ebc0a5d2 | 2026-05-13 | Warnings, Adverse reactions | 209167 ANDA209167 71335-1587 |
| Tadalafil | TADALAFIL | Bryant Ranch Prepack | f8def23c-55ea-4796-9735-dbcb25104835 | 2026-05-13 | Warnings, Adverse reactions | 209167 ANDA209167 71335-1620 |
| Tadalafil | TADALAFIL | Accord Healthcare Inc. | eedf3ad9-7d40-496d-b1a9-6200010c18e1 | 2026-04-16 | Warnings, Adverse reactions | 209167 ANDA209167 16729-369 16729-370 16729-371 16729-372 |
| Tadalafil | TADALAFIL | Preferred Pharmaceuticals Inc. | affacb88-4af3-4ce9-961b-7fc37b169e9a | 2026-01-12 | Warnings, Adverse reactions | 209167 ANDA209167 68788-8153 |
| Tadalafil | TADALAFIL | Northwind Health Company, LLC | f3092f5a-b976-91ab-e053-2995a90a9b50 | 2026-01-01 | Warnings, Adverse reactions | 209167 ANDA209167 |
| Tadalafil | TADALAFIL | Northwind Health Company, LLC | f317fe1e-d7c4-fb8b-e053-2a95a90a5445 | 2026-01-01 | Warnings, Adverse reactions | 209167 ANDA209167 |
| Tadalafil | TADALAFIL | NuCare Pharmaceuticals,Inc. | cf35291b-b05b-1182-e053-2995a90a8dee | 2025-02-10 | Warnings, Adverse reactions | 209167 ANDA209167 68071-2553 |
| Tadalafil | TADALAFIL | NuCare Pharmaceuticals,Inc. | 9f83ea2e-8ee8-ab6d-e053-2995a90a1e96 | 2024-06-20 | Warnings, Adverse reactions | 209167 ANDA209167 68071-5186 |
| Tadalafil | TADALAFIL | NuCare Pharmaceuticals,Inc. | a0acad71-8ae3-2827-e053-2995a90a20b3 | 2024-06-20 | Warnings, Adverse reactions | 209167 ANDA209167 68071-5202 |
| Tadalafil | TADALAFIL | Proficient Rx LP | 7a105ef9-7129-4ce1-bd8d-ae316bf348e2 | 2022-11-01 | Warnings, Adverse reactions | 209167 ANDA209167 71205-720 |
| Tadalafil | TADALAFIL | Proficient Rx LP | b539e862-d5d4-4989-a3dd-1eba66285d53 | 2022-05-01 | Warnings, Adverse reactions | 209167 ANDA209167 71205-502 |
| Tadalafil | TADALAFIL | Proficient Rx LP | 31c05a53-7282-46d0-81bd-108defe6fb38 | 2022-04-01 | Warnings, Adverse reactions | 209167 ANDA209167 71205-269 |
| Tadalafil | TADALAFIL | Proficient Rx LP | 6fa9d4fa-86c9-4791-b28b-78e8b9341cea | 2022-04-01 | Warnings, Adverse reactions | 209167 ANDA209167 71205-268 |
| Tadalafil | TADALAFIL | Asclemed USA, Inc. | aba646fe-70c2-1abb-e053-2995a90aa16d | 2022-01-28 | Warnings, Adverse reactions | 209167 ANDA209167 76420-126 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16729-369 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-369 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-369 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-369 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-369 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-369 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-369 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-370 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-370 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-370 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-370 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-370 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-370 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-370 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-371 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-371 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-371 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-371 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-371 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-372 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-372 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-372 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-372 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-372 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-372 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 16729-372 | Tadalafil | Tadalafil | Accord Healthcare Inc. | ANDA | Current |
| 50090-6150 | Tadalafil | Tadalafil | A-S Medication Solutions | ANDA | Current |
| 50436-0370 | Tadalafil | Tadalafil | Unit Dose Services | ANDA | Current |
| 50436-0370 | Tadalafil | Tadalafil | Unit Dose Services | ANDA | Current |
| 50436-0372 | Tadalafil | Tadalafil | Unit Dose Services | ANDA | Current |
| 63629-8409 | Tadalafil | Tadalafil | Bryant Ranch Prepack | ANDA | Current |
| 63629-8409 | Tadalafil | Tadalafil | Bryant Ranch Prepack | ANDA | Current |
| 63629-8409 | Tadalafil | Tadalafil | Bryant Ranch Prepack | ANDA | Current |
| 68071-2553 | Tadalafil | Tadalafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5186 | Tadalafil | Tadalafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5186 | Tadalafil | Tadalafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5202 | Tadalafil | Tadalafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5202 | Tadalafil | Tadalafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5272 | Tadalafil | Tadalafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5272 | Tadalafil | Tadalafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-8153 | Tadalafil | Tadalafil | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-2972 | Tadalafil | Tadalafil | REMEDYREPACK INC. | ANDA | Current |
| 70518-2972 | Tadalafil | Tadalafil | REMEDYREPACK INC. | ANDA | Current |
| 70934-795 | Tadalafil | Tadalafil | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-268 | Tadalafil | Tadalafil | Proficient Rx LP | ANDA | Current |
| 71205-268 | Tadalafil | Tadalafil | Proficient Rx LP | ANDA | Current |
| 71205-268 | Tadalafil | Tadalafil | Proficient Rx LP | ANDA | Current |
| 71205-268 | Tadalafil | Tadalafil | Proficient Rx LP | ANDA | Current |
| 71205-269 | Tadalafil | Tadalafil | Proficient Rx LP | ANDA | Current |
| 71205-269 | Tadalafil | Tadalafil | Proficient Rx LP | ANDA | Current |
| 71205-269 | Tadalafil | Tadalafil | Proficient Rx LP | ANDA | Current |
| 71205-269 | Tadalafil | Tadalafil | Proficient Rx LP | ANDA | Current |
| 71205-502 | Tadalafil | Tadalafil | Proficient Rx LP | ANDA | Current |
| 71205-502 | Tadalafil | Tadalafil | Proficient Rx LP | ANDA | Current |
| 71205-502 | Tadalafil | Tadalafil | Proficient Rx LP | ANDA | Current |
| 71205-720 | Tadalafil | Tadalafil | Proficient Rx LP | ANDA | Current |
| 71335-1587 | Tadalafil | Tadalafil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1587 | Tadalafil | Tadalafil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1587 | Tadalafil | Tadalafil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1620 | Tadalafil | Tadalafil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1620 | Tadalafil | Tadalafil | Bryant Ranch Prepack | ANDA | Current |
| 71455-597 | TADALAFIL | TADALAFIL | UNYTER ENTERPRISES | ANDA | Current |
| 76420-126 | Tadalafil | Tadalafil | Asclemed USA, Inc. | ANDA | Current |
| 76420-126 | Tadalafil | Tadalafil | Asclemed USA, Inc. | ANDA | Current |