Drugs@FDA: FDA Approved Drug Products
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 |
|---|---|---|---|---|---|
| 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 | 078173 | MYLAN PHARMS INC |
| 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 LABS LTD |
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 | 078173 | MYLAN PHARMS INC |
| 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 LABS LTD |
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