Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206431
Company: TARO PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE SODIUM SULFATE;POTASSIUM SULFATE;MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION;ORAL None (Tentative Approval) None 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
10/26/2018 ORIG-1 Tentative Approval STANDARD Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206431Orig1s000TALtr.pdf

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