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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203352
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)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203352Orig1s000ltr.pdf
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