Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204722
Company: PANACEA
Company: PANACEA
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 |
---|---|---|---|---|---|---|---|
01/11/2017 | ORIG-1 | Approval |
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 |