Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212903
Company: ANNORA PHARMA
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)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212903Orig1s000TAltr.pdf |