Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203432
Company: AJANTA PHARMA LTD
Company: AJANTA PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 07/31/2015 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/20/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2019 | SUPPL-7 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2019 | SUPPL-5 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2019 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |