Application 211497
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PENICILLAMINE | PENICILLAMINE | TABLET;ORAL | 250MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211497-001 | PENICILLAMINE | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 |
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 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | c0c555d07b60… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211497-001 | PENICILLAMINE | 250MG | TABLET / ORAL | 2020-02-13 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Penicillamine | PENICILLAMINE | Breckenridge Pharmaceutical, Inc. | 1320f46b-e243-4e93-b9c9-ad8eb7828de5 | 2026-08-14 | Boxed warning, Warnings, Adverse reactions | Penicillamine PENICILLAMINE |
| penicillamine | PENICILLAMINE | Par Health USA, LLC | 72ee469c-f9ef-4bb4-922f-5d71276664a5 | 2026-07-31 | Warnings, Adverse reactions | penicillamine PENICILLAMINE |
| Penicillamine | PENICILLAMINE | Par Health USA, LLC | 01e79d8f-8c74-4f48-b761-9f225fabf93d | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | Penicillamine PENICILLAMINE |
| Cuprimine | PENICILLAMINE | Bausch Health US, LLC | 80e736d3-2017-4d68-94b4-38255c3c59c6 | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | PENICILLAMINE |
| Depen | PENICILLAMINE | Viatris Specialty LLC | 38f8ae60-b354-11de-8a39-0800200c9a66 | 2025-09-21 | Boxed warning, Warnings, Adverse reactions | PENICILLAMINE |
| Penicillamine | PENICILLAMINE | Granules Pharmaceuticals Inc. | f658b20a-269f-4e78-a79b-a56a5ed8dc1b | 2025-05-06 | Boxed warning, Warnings, Adverse reactions | Penicillamine PENICILLAMINE |
| AAGYLUR | PENICILLAMINE | Cycle Pharmaceuticals Ltd. | ddbd84a9-1c39-42e0-a271-138784e1dc58 | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | PENICILLAMINE |
| Penicillamine | PENICILLAMINE | Actavis Pharma, Inc. | 594d7a82-af1d-41c4-98ee-0ea6895fc237 | 2024-09-25 | Boxed warning, Warnings, Adverse reactions | Penicillamine PENICILLAMINE |
| Penicillamine | PENICILLAMINE | Lupin Pharmaceuticals, Inc. | f6ecaf47-902f-4378-b524-7a88f20ba138 | 2022-12-28 | Boxed warning, Warnings, Adverse reactions | Penicillamine PENICILLAMINE |
| Penicillamine | PENICILLAMINE | Navinta LLC | 064fb48d-aa34-4e52-9295-10f2ca4c77dc | 2022-12-02 | Warnings, Adverse reactions | Penicillamine PENICILLAMINE |
| Penicillamine | PENICILLAMINE | Proficient Rx LP | c92335c6-f6fa-4768-9401-55c6b7f87699 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | Penicillamine PENICILLAMINE |
| Penicillamine | PENICILLAMINE | Dr. Reddy's Laboratories Inc. | 15d08594-83a9-cc7a-92ef-1bac0427e121 | 2020-08-05 | Boxed warning, Warnings, Adverse reactions | Penicillamine PENICILLAMINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 62176 | ORIG | 2020-03-17 |