Application 220373
- Type
- ANDA
- Sponsor
- CAPLIN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | SOLUTION;INTRAVENOUS | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | No | No |
| 002 | POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | SOLUTION;INTRAVENOUS | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | No | No |
| 003 | POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | SOLUTION;INTRAVENOUS | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A220373-001 | POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2026-03-12 | |
| A220373-002 | POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2026-03-12 | |
| A220373-003 | POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2026-03-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A220373-001 | AP |
| A220373-002 | AP |
| A220373-003 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A220373-001 | POTASSIUM PHOSPHATES | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2026-03-12 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A220373-002 | POTASSIUM PHOSPHATES | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2026-03-12 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A220373-003 | POTASSIUM PHOSPHATES | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION / INTRAVENOUS | AP | 2026-03-12 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A220373-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A220373-002 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A220373-003 | AP | 1 | 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 |
|---|---|---|---|---|---|---|
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATES | GLENMARK PHARMACEUTICALS INC., USA | 70c7710c-a354-4941-bd46-e64d6ea6b5dc | 2026-03-20 | Warnings, Adverse reactions | 220373 ANDA220373 |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATES | Caplin Steriles Limited | fbbd8380-9848-4862-8c73-2f53fcdf7120 | 2026-03-16 | Warnings, Adverse reactions | 220373 ANDA220373 |