Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203062
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA 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 |
---|---|---|---|---|---|---|---|
07/01/2013 | 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 |
---|---|---|---|---|---|
01/29/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
11/09/2015 | SUPPL-1 | 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 | 201914 | GLENMARK PHARMS LTD |
RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203334 | JUBILANT GENERICS |
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 BIOTEC LTD |
RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078739 | SANDOZ |
RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 207835 | UNICHEM |
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 | MERCK |
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 | 201914 | GLENMARK PHARMS LTD |
RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 203334 | JUBILANT GENERICS |
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 BIOTEC LTD |
RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078739 | SANDOZ |
RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 207835 | UNICHEM |
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