Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212555
Company: GLENMARK PHARMS LTD
Company: GLENMARK PHARMS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NINTEDANIB | NINTEDANIB ESYLATE | EQ 100MG BASE | CAPSULE;ORAL | None (Tentative Approval) | None | No | No |
| NINTEDANIB | NINTEDANIB ESYLATE | EQ 150MG BASE | CAPSULE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 12/23/2025 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212555Orig1s000TAltr.pdf |