Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203146
Company: MACLEODS PHARMS LTD
Company: MACLEODS PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING;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 |
---|---|---|---|---|---|---|---|
09/19/2014 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203146Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/07/2023 | SUPPL-22 | Labeling-Patient Package Insert, Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
11/29/2019 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
RIZATRIPTAN BENZOATE
TABLET, ORALLY DISINTEGRATING;ORAL; EQ 5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203062 | AUROBINDO PHARMA LTD |
RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203146 | MACLEODS PHARMS LTD |
RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203478 | NATCO PHARMA LTD |
RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 204722 | PANACEA |
TABLET, ORALLY DISINTEGRATING;ORAL; EQ 10MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MAXALT-MLT | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 020865 | ORGANON |
RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203062 | AUROBINDO PHARMA LTD |
RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203146 | MACLEODS PHARMS LTD |
RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203478 | NATCO PHARMA LTD |
RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 204722 | PANACEA |