Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204604
Company: AMNEAL PHARMS
Company: AMNEAL 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 |
---|---|---|---|---|---|---|---|
09/04/2015 | 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 |
---|---|---|---|---|---|
12/06/2019 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
12/06/2019 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
12/06/2019 | SUPPL-1 | 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 | 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 | 209012 | RISING PHARMA |
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 |