Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077440
Company: MOUNTAIN
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/08/2006 ORIG-1 Approval

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 077440 MOUNTAIN
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 077440 MOUNTAIN
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

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