Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091588
Company: STRIDES PHARMA
Company: STRIDES PHARMA
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 |
---|---|---|---|---|---|---|---|
08/03/2012 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091588Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/02/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
10/02/2020 | SUPPL-17 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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07/27/2018 | SUPPL-14 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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06/22/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
06/22/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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07/22/2013 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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12/13/2012 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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09/12/2012 | SUPPL-1 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |