Application 212759
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PIRFENIDONE | PIRFENIDONE | TABLET;ORAL | 267MG | No | No |
| 002 | PIRFENIDONE | PIRFENIDONE | TABLET;ORAL | 801MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212759-001 | PIRFENIDONE | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | |
| A212759-002 | PIRFENIDONE | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212759-001 | AB |
| A212759-002 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | bb7c543d1eb4… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A212759-001 | PIRFENIDONE | 267MG | TABLET / ORAL | AB | 2022-01-25 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A212759-002 | PIRFENIDONE | 801MG | TABLET / ORAL | AB | 2022-01-25 | 1c564ffb4f44… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A212759-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212759-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212759-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212759-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212759-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212759-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212759-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212759-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212759-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212759-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212759-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212759-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212759-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212759-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212759-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212759-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212759-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212759-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A212759-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A212759-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212759-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212759-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212759-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212759-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212759-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212759-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A212759-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A212759-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212759-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212759-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A212759-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A212759-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A212759-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A212759-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A212759-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A212759-002 | AB | 1 | bb7c543d1eb4… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212759-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212759-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A212759-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A212759-002 | AB | 1 | 1c564ffb4f44… |
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 |
|---|---|---|---|---|---|---|
| Pirfenidone | PIRFENIDONE | Teva Pharmaceuticals, Inc. | cbbd14a4-b7e6-4147-9314-bb715dfb1a51 | 2024-10-21 | Warnings, Adverse reactions | 212759 ANDA212759 0480-3611 0480-3610 |