Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203795
Company: JUBILANT GENERICS
Company: JUBILANT GENERICS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE;ORAL | Discontinued | None | No | No |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE;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 |
|---|---|---|---|---|---|---|---|
| 02/27/2015 | 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 |
|---|---|---|---|---|---|
| 11/13/2020 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/13/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/13/2020 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 11/13/2020 | SUPPL-3 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/07/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |