Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077419
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/02/2008 | ORIG-1 | Approval |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077419lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/077419Orig1Approv.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/10/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
02/26/2013 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
11/22/2010 | SUPPL-13 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/02/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077419lbl.pdf |
POTASSIUM CHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL; 8MEQ
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KLOR-CON | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203106 | UPSHER SMITH LABS |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 077419 | ACTAVIS LABS FL INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208864 | ADARE PHARMS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214686 | GRANULES |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203002 | LUPIN LTD |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204828 | NOVEL LABS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200185 | PADAGIS US |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209026 | PRINSTON INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205549 | STRIDES PHARMA |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208445 | ZYDUS PHARMS |
CAPSULE, EXTENDED RELEASE;ORAL; 10MEQ
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KLOR-CON | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203106 | UPSHER SMITH LABS |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 077419 | ACTAVIS LABS FL INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208864 | ADARE PHARMS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202128 | AMNEAL PHARMS |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214686 | GRANULES |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203002 | LUPIN LTD |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204828 | NOVEL LABS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200185 | PADAGIS US |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209026 | PRINSTON INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205549 | STRIDES PHARMA |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208445 | ZYDUS PHARMS |