Application 086809
- Type
- ANDA
- Sponsor
- CHARTWELL RX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SPIRONOLACTONE | SPIRONOLACTONE | TABLET;ORAL | 25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A086809-001 | SPIRONOLACTONE | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 |
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 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A086809-001 | SPIRONOLACTONE | 25MG | TABLET / ORAL | Approved before 1982 | 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 |
|---|---|---|---|---|---|---|
| spironolactone | SPIRONOLACTONE | REMEDYREPACK INC. | 8b76a904-6c99-485a-a05f-13a36c5f720c | 2026-08-04 | Warnings, Adverse reactions | spironolactone SPIRONOLACTONE |
| SPIRONOLACTONE | SPIRONOLACTONE | Sun Pharmaceutical Industries, Inc. | c23b6b9b-aec3-48a8-a518-76e4097f6479 | 2026-07-31 | Warnings, Adverse reactions | SPIRONOLACTONE SPIRONOLACTONE |
| SPIRONOLACTONE | SPIRONOLACTONE | Redpharm Drug | 57d1c333-c229-54aa-e063-6394a90a84ce | 2026-07-30 | Warnings, Adverse reactions | SPIRONOLACTONE SPIRONOLACTONE |
| Spironolactone | SPIRONOLACTONE | PD-Rx Pharmaceuticals, Inc. | 73564b3d-8ede-4008-b75c-1277153b5bb6 | 2026-07-17 | Warnings, Adverse reactions | Spironolactone SPIRONOLACTONE |
| Spironolactone | SPIRONOLACTONE | PD-Rx Pharmaceuticals, Inc. | 8a66d90e-5450-4716-8c01-e7dc1967d00d | 2026-07-17 | Warnings, Adverse reactions | Spironolactone SPIRONOLACTONE |
| Spironolactone | SPIRONOLACTONE | PD-Rx Pharmaceuticals, Inc. | 8cbe2215-744c-438a-b3d6-b7d6ae769231 | 2026-07-17 | Warnings, Adverse reactions | Spironolactone SPIRONOLACTONE |
| SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | be4aa233-1555-4972-858e-46343a710558 | 2026-07-16 | Warnings, Adverse reactions | SPIRONOLACTONE SPIRONOLACTONE |
| SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | 11d06acd-1351-4afd-a16a-f035758e2a27 | 2026-07-15 | Warnings, Adverse reactions | SPIRONOLACTONE SPIRONOLACTONE |
| SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ca194a2a-ed16-40f6-a78c-45c5f3392170 | 2026-07-15 | Warnings, Adverse reactions | SPIRONOLACTONE SPIRONOLACTONE |
| SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ebc4efec-7895-4298-8e75-360bb7992f8d | 2026-07-15 | Warnings, Adverse reactions | SPIRONOLACTONE SPIRONOLACTONE |
| Spironolactone | SPIRONOLACTONE | REMEDYREPACK INC. | 8f0291a9-c8a6-4298-a540-23abc01fae09 | 2026-07-09 | Warnings, Adverse reactions | Spironolactone SPIRONOLACTONE |
| Spironolactone | SPIRONOLACTONE | Coupler LLC | 56050192-c499-64bd-e063-6294a90acbeb | 2026-07-07 | Warnings, Adverse reactions | Spironolactone SPIRONOLACTONE |
| spironolactone | SPIRONOLACTONE | Camber Pharmaceuticals, Inc. | e61269b2-823a-49e8-b55f-ef0b8b1dbcde | 2026-07-03 | Warnings, Adverse reactions | spironolactone SPIRONOLACTONE |
| SPIRONOLACTONE | SPIRONOLACTONE | ATLANTIC BIOLOGICALS CORP. | 122558a0-57bb-4195-9adf-d37b049cbfb5 | 2026-07-02 | Warnings, Adverse reactions | SPIRONOLACTONE SPIRONOLACTONE |
| Spironolactone | SPIRONOLACTONE | Safecor Health LLC | 7057c090-67c2-414c-9077-bed18ad4b0b3 | 2026-07-01 | Warnings, Adverse reactions | Spironolactone SPIRONOLACTONE |
| Spironolactone | SPIRONOLACTONE | REMEDYREPACK INC. | 6518ba72-89e4-4f2f-b334-9ef759b696f8 | 2026-06-30 | Warnings, Adverse reactions | Spironolactone SPIRONOLACTONE |
| Spironolactone | SPIRONOLACTONE | Coupler LLC | 53454970-2c0f-54c3-e063-6294a90aac0a | 2026-06-02 | Warnings, Adverse reactions | Spironolactone SPIRONOLACTONE |
| Spironolactone | SPIRONOLACTONE | REMEDYREPACK INC. | b119ed8a-289a-46c5-9778-6b07e4c061c4 | 2026-06-01 | Warnings, Adverse reactions | Spironolactone SPIRONOLACTONE |
| Spironolactone | SPIRONOLACTONE | Bryant Ranch Prepack | 31aeab13-8f71-49f1-b101-8b0abb21b0dc | 2026-06-01 | Warnings, Adverse reactions | Spironolactone SPIRONOLACTONE |
| Spironolactone | SPIRONOLACTONE | PD-Rx Pharmaceuticals, Inc. | 3487305c-25a6-4e82-923c-3e4dd638c988 | 2026-05-28 | Warnings, Adverse reactions | Spironolactone SPIRONOLACTONE |