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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204135
Company: BRECKENRIDGE PHARMS

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 17.5G;3.13G;1.6G 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
11/14/2016 ORIG-1 Tentative Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204135Orig1s000TAltr.pdf
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