Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201294
Company: APOTEX CORP
Company: APOTEX CORP
| 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 |
|---|---|---|---|---|---|---|---|
| 08/03/2012 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201294Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/16/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/16/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/14/2013 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/13/2012 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |