Drugs@FDA: FDA-Approved Drugs
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 |
---|---|---|---|---|---|
01/22/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
01/22/2020 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
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 | 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 | 202047 | PHARMA LIFE |
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 |
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 | 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 | 202047 | PHARMA LIFE |
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 |
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