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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203102
Company: PADDOCK LLC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM 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
08/18/2016 ORIG-1 Tentative Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203102Orig1s000TAltr.pdf
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