Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203352
Company: JUBILANT CADISTA
Company: JUBILANT CADISTA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Discontinued | None | No | No |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 27MG/3ML (9MG/ML) | SOLUTION;INJECTION | Discontinued | 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 |
---|---|---|---|---|---|---|---|
05/18/2016 | 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/2016/203352Orig1s000ltr.pdf |