Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214657
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
Pemetrexed Pemetrexed 100MG/4ML (25 mg/mL) SOLUTION;INTRAVENOUS None (Tentative Approval) None No No
Pemetrexed Pemetrexed 500MG/20ML (25MG/ML) SOLUTION; INJECTION None (Tentative Approval) None No No
Pemetrexed Pemetrexed 1000MG/40ML (25MG/ML) SOLUTION; INJECTION 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
05/06/2021 ORIG-1 Tentative Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214657Orig1s000TAltr.pdf

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