Application 213986
- Type
- ANDA
- Sponsor
- TORRENT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POTASSIUM CITRATE | POTASSIUM CITRATE | TABLET, EXTENDED RELEASE;ORAL | 5MEQ | No | No |
| 002 | POTASSIUM CITRATE | POTASSIUM CITRATE | TABLET, EXTENDED RELEASE;ORAL | 10MEQ | No | No |
| 003 | POTASSIUM CITRATE | POTASSIUM CITRATE | TABLET, EXTENDED RELEASE;ORAL | 15MEQ | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213986-001 | POTASSIUM CITRATE | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | ||
| A213986-002 | POTASSIUM CITRATE | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | ||
| A213986-003 | POTASSIUM CITRATE | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 |
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 | A213986-001 | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A213986-002 | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A213986-003 | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213986-001 | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213986-002 | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213986-003 | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213986-001 | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213986-002 | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213986-003 | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213986-001 | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213986-002 | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213986-003 | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213986-001 | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213986-002 | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213986-003 | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213986-001 | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213986-002 | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213986-003 | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213986-001 | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213986-002 | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213986-003 | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213986-001 | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213986-002 | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213986-003 | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213986-001 | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213986-002 | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213986-003 | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213986-001 | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213986-002 | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213986-003 | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213986-001 | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213986-002 | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213986-003 | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213986-001 | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213986-002 | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213986-003 | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213986-001 | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213986-002 | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213986-003 | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213986-001 | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE / ORAL | 2024-02-06 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-02-18 07:12 UTC | 2024-02 | A213986-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A213986-002 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A213986-003 | 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 |
|---|---|---|---|---|---|---|
| Potassium Citrate | POTASSIUM CITRATE | Golden State Medical Supply, Inc. | cb09c63d-f3f0-5d6b-e053-2995a90acd44 | 2023-10-31 | Warnings, Adverse reactions | Potassium Citrate POTASSIUM CITRATE |
| Potassium Citrate | POTASSIUM CITRATE | Zydus Lifesciences Limited | 39f46084-fc4b-4bfc-91cb-9be7e647655a | 2023-10-03 | Warnings, Adverse reactions | Potassium Citrate POTASSIUM CITRATE |
| Potassium Citrate | POTASSIUM CITRATE | Zydus Pharmaceuticals (USA) Inc. | 1a839f91-9bbd-4f46-b350-c5e8074b5db7 | 2023-10-03 | Warnings, Adverse reactions | Potassium Citrate POTASSIUM CITRATE |
| POTASSIUM CITRATE | POTASSIUM CITRATE | Bryant Ranch Prepack | b977c77b-c212-408e-adac-61736e5ed362 | 2023-09-18 | Warnings, Adverse reactions | POTASSIUM CITRATE POTASSIUM CITRATE |
| POTASSIUM CITRATE | POTASSIUM CITRATE | Bryant Ranch Prepack | d2e6ef87-f5d7-409a-91ed-ff0a4763c3bd | 2023-09-15 | Warnings, Adverse reactions | POTASSIUM CITRATE POTASSIUM CITRATE |
| Potassium Citrate | POTASSIUM CITRATE | Actavis Pharma, Inc. | ac173781-486b-461c-97ae-8b5c69e20792 | 2022-06-01 | Warnings, Adverse reactions | Potassium Citrate POTASSIUM CITRATE |
| POTASSIUM CITRATE | POTASSIUM CITRATE | XLCare Pharmaceuticals, Inc. | 360a1012-4bdb-473a-8f1f-4550d3b51343 | 2022-01-21 | Warnings, Adverse reactions | POTASSIUM CITRATE POTASSIUM CITRATE |
| POTASSIUM CITRATE | POTASSIUM CITRATE | Camber Pharmaceuticals, Inc | ea933654-e8d2-4662-9a9a-4a6d79a9fb20 | 2022-01-19 | Warnings, Adverse reactions | POTASSIUM CITRATE POTASSIUM CITRATE |
| UROCIT-K | POTASSIUM CITRATE | Mission Pharmacal Company | 72cdea1b-2240-41db-987d-86d5c6aaa978 | 2021-12-02 | Warnings, Adverse reactions | POTASSIUM CITRATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.