Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 211090
Company: BIOCON PHARMA LTD
Company: BIOCON PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 100MG BASE/VIAL | POWDER;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 05/23/2019 | ORIG-1 | Tentative Approval | STANDARD |
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