Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213471
Company: AUROBINDO PHARMA LTD
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/PACKET | GRANULE;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 |
---|---|---|---|---|---|---|---|
02/18/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/30/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
07/30/2021 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
MONTELUKAST SODIUM
GRANULE;ORAL; EQ 4MG BASE/PACKET
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/PACKET | GRANULE;ORAL | Prescription | No | AB | 203438 | AJANTA PHARMA LTD |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE/PACKET | GRANULE;ORAL | Prescription | No | AB | 213471 | AUROBINDO PHARMA LTD |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE/PACKET | GRANULE;ORAL | Prescription | No | AB | 202906 | DR REDDYS LABS LTD |
MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE/PACKET | GRANULE;ORAL | Prescription | No | AB | 210431 | TORRENT |
SINGULAIR | MONTELUKAST SODIUM | EQ 4MG BASE/PACKET | GRANULE;ORAL | Prescription | Yes | AB | 021409 | ORGANON |