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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212903
Company: ANNORA PHARMA

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 17.5GM/BOT;3.13GM/BOT;1.6GM/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
06/15/2021 ORIG-1 Tentative Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212903Orig1s000TAltr.pdf
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