Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 220373
Company: CAPLIN
Company: CAPLIN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/12/2026 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
POTASSIUM PHOSPHATES
SOLUTION;INTRAVENOUS; 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216274 | AM REGENT |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216344 | AMNEAL |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 220373 | CAPLIN |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217892 | CIPLA |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 212832 | FRESENIUS KABI USA |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217726 | SOMERSET THERAPS LLC |
SOLUTION;INTRAVENOUS; 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216274 | AM REGENT |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216344 | AMNEAL |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 220373 | CAPLIN |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217892 | CIPLA |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 212832 | FRESENIUS KABI USA |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217459 | HOSPIRA |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217726 | SOMERSET THERAPS LLC |
SOLUTION;INTRAVENOUS; 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216274 | AM REGENT |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216344 | AMNEAL |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 220373 | CAPLIN |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217892 | CIPLA |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 212832 | FRESENIUS KABI USA |