Drugs@FDA: FDA-Approved Drugs
Company: AUROBINDO PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE;ORAL | Prescription | AB | No | No |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE;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/2012/202096Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/19/2022 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
08/14/2020 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
11/05/2019 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
11/05/2019 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
07/23/2018 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
12/08/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
12/08/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
05/10/2013 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
11/30/2012 | SUPPL-4 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
11/30/2012 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
MONTELUKAST SODIUM
TABLET, CHEWABLE;ORAL; EQ 4MG 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 4MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 205107 | AMNEAL PHARMS |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 205695 | ANBISON LAB |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 202096 | AUROBINDO PHARMA LTD |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 207464 | CHARTWELL MOLECULAR |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 201581 | DR REDDYS LABS LTD |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 204093 | HETERO LABS LTD V |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 200405 | LANNETT CO INC |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 203582 | MACLEODS PHARMS LTD |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 209011 | RISING |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 091414 | SANDOZ INC |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 078723 | TEVA PHARMS |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 090984 | TORRENT PHARMS LTD |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 203037 | UNIMARK REMEDIES LTD |
SINGULAIR | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE;ORAL | Prescription | Yes | AB | 020830 | ORGANON |
TABLET, CHEWABLE;ORAL; EQ 5MG 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 5MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 205107 | AMNEAL PHARMS |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 205695 | ANBISON LAB |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 202096 | AUROBINDO PHARMA LTD |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 207464 | CHARTWELL MOLECULAR |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 201581 | DR REDDYS LABS LTD |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 204093 | HETERO LABS LTD V |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 200405 | LANNETT CO INC |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 203582 | MACLEODS PHARMS LTD |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 209011 | RISING |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 091414 | SANDOZ INC |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 078723 | TEVA PHARMS |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 090984 | TORRENT PHARMS LTD |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 203037 | UNIMARK REMEDIES LTD |
SINGULAIR | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE;ORAL | Prescription | Yes | AB | 020830 | ORGANON |