Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212789
Company: HETERO LABS LTD V
Company: HETERO LABS LTD V
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID | CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE | 12GM/PACKET;3.5GM/PACKET;10MG/PACKET | FOR SOLUTION;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/18/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212789Orig1s000ltr.pdf |