Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075604
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 | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | No | No |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | 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 |
---|---|---|---|---|---|---|---|
04/10/2002 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75604.ap.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/24/2008 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
12/24/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
10/09/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
11/29/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
POTASSIUM CHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 10MEQ
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KLOR-CON M10 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 074726 | UPSHER SMITH LABS |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 075604 | ACTAVIS LABS FL INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 076368 | ADARE PHARMS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 212861 | AMNEAL |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 214422 | ASCENT PHARMS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 203562 | GLENMARK PHARMS LTD |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 214452 | GRANULES |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 214395 | GUANGZHOU NOVAKEN |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 216269 | MACLEODS PHARMS LTD |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 206347 | NOVEL LABS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 209922 | PRINSTON INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 216321 | RUBICON |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 210395 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 20MEQ
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KLOR-CON M20 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 074726 | UPSHER SMITH LABS |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 075604 | ACTAVIS LABS FL INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 076368 | ADARE PHARMS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 212861 | AMNEAL |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 214422 | ASCENT PHARMS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 203562 | GLENMARK PHARMS LTD |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 214452 | GRANULES |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 214395 | GUANGZHOU NOVAKEN |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 216269 | MACLEODS PHARMS LTD |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 206347 | NOVEL LABS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 209922 | PRINSTON INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 216321 | RUBICON |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 210395 | ZYDUS PHARMS |