Drugs@FDA: FDA-Approved Drugs
Company: TEVA PHARMS
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 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078605Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/23/2020 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
04/01/2020 | SUPPL-12 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
05/18/2018 | SUPPL-11 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
11/12/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
03/16/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
03/16/2015 | SUPPL-6 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
06/25/2013 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
02/06/2013 | SUPPL-3 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
12/13/2012 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
10/12/2012 | SUPPL-1 | Labeling-Patient Package Insert, 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 |