Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215179
Company: SHILPA
Company: SHILPA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PEMETREXED | PEMETREXED DISODIUM | EQ 100MG/10ML BASE (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
PEMETREXED | PEMETREXED DISODIUM | EQ 500MG/50ML BASE (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
PEMETREXED | PEMETREXED DISODIUM | EQ 1GM/100ML BASE (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | 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 |
---|---|---|---|---|---|---|---|
05/22/2023 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215179s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215179Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/215179Orig1s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/22/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215179s000lbl.pdf |