Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 203269
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 02/18/2016 | 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 |
|---|---|---|---|---|---|
| 05/19/2016 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
RIZATRIPTAN BENZOATE
TABLET;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;ORAL | Prescription | No | AB | 203269 | ALKEM LABS LTD |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 202490 | AUROBINDO PHARMA LTD |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 077526 | CELLTRION |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 202047 | ECI PHARMS LLC |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 204090 | EMCURE PHARMS LTD |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 201967 | GLENMARK GENERICS |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 204339 | INVAGEN PHARMS |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 203252 | JUBILANT GENERICS |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 203147 | MACLEODS PHARMS LTD |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 201993 | MYLAN PHARMS INC |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 200482 | NATCO PHARMA LTD |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 079230 | SANDOZ |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 077263 | TEVA PHARMS |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 207836 | UNICHEM LABS LTD |
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MAXALT | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020864 | MERCK |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 203269 | ALKEM LABS LTD |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 202490 | AUROBINDO PHARMA LTD |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077526 | CELLTRION |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 202047 | ECI PHARMS LLC |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 204090 | EMCURE PHARMS LTD |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 201967 | GLENMARK GENERICS |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 204339 | INVAGEN PHARMS |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 203252 | JUBILANT GENERICS |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 203147 | MACLEODS PHARMS LTD |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 201993 | MYLAN PHARMS INC |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 200482 | NATCO PHARMA LTD |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 079230 | SANDOZ |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077263 | TEVA PHARMS |
| RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207836 | UNICHEM LABS LTD |
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