Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209758
Company: TEVA PHARMS USA INC
Company: TEVA PHARMS USA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POTASSIUM CITRATE | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 03/05/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
POTASSIUM CITRATE
TABLET, EXTENDED RELEASE;ORAL; 5MEQ
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CITRATE | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214420 | ASCENT PHARMS INC |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214426 | EYWA |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 077440 | RISING |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206813 | STRIDES PHARMA |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209758 | TEVA PHARMS USA INC |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203546 | ZYDUS PHARMS |
| UROCIT-K | POTASSIUM CITRATE | 5MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 019071 | MISSION PHARMA |
TABLET, EXTENDED RELEASE;ORAL; 10MEQ
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CITRATE | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212779 | ANI PHARMS |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214420 | ASCENT PHARMS INC |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212799 | BIONPHARMA |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214426 | EYWA |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 077440 | RISING |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206813 | STRIDES PHARMA |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209758 | TEVA PHARMS USA INC |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203546 | ZYDUS PHARMS |
| UROCIT-K | POTASSIUM CITRATE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 019071 | MISSION PHARMA |
TABLET, EXTENDED RELEASE;ORAL; 15MEQ
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CITRATE | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212779 | ANI PHARMS |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214420 | ASCENT PHARMS INC |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212799 | BIONPHARMA |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214426 | EYWA |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206813 | STRIDES PHARMA |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209758 | TEVA PHARMS USA INC |
| POTASSIUM CITRATE | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203546 | ZYDUS PHARMS |
| UROCIT-K | POTASSIUM CITRATE | 15MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 019071 | MISSION PHARMA |