Drugs@FDA: FDA-Approved Drugs
Company: CHARTWELL MOLECULAR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | AB | 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/2012/201522Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/07/2023 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
08/07/2023 | SUPPL-17 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
10/08/2020 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/08/2020 | SUPPL-12 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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10/08/2020 | SUPPL-10 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
07/23/2018 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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06/02/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
08/22/2013 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
01/06/2016 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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01/31/2013 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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09/18/2012 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
MONTELUKAST SODIUM
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 202717 | ACCORD HLTHCARE |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 204604 | AMNEAL PHARMS |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 205683 | ANBISON LAB |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 202468 | AUROBINDO PHARMA LTD |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 201522 | CHARTWELL MOLECULAR |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207463 | CIPLA |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 201582 | DR REDDYS LABS LTD |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 090926 | GLENMARK PHARMS LTD |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 209012 | GRAVITI PHARMS |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 202843 | HETERO LABS LTD V |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 203366 | MACLEODS PHARMS LTD |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 200889 | SANDOZ INC |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 078605 | TEVA PHARMS |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 201515 | TORRENT PHARMS LTD |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 204290 | UNICHEM |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 202859 | UNIMARK REMEDIES LTD |
SINGULAIR | MONTELUKAST SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020829 | ORGANON |