Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202040
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | AB | No | No |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 40MG 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 |
---|---|---|---|---|---|---|---|
06/27/2017 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/13/2024 | SUPPL-6 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
ELETRIPTAN HYDROBROMIDE
TABLET;ORAL; EQ 20MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 205186 | AJANTA PHARMA LTD |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 210708 | AUROBINDO PHARMA |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 215467 | BEXIMCO PHARMS USA |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 205152 | MYLAN |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 202040 | TEVA PHARMS USA |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 206409 | ZYDUS PHARMS |
RELPAX | ELETRIPTAN HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021016 | UPJOHN |
TABLET;ORAL; EQ 40MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 205186 | AJANTA PHARMA LTD |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 210708 | AUROBINDO PHARMA |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 215467 | BEXIMCO PHARMS USA |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 205152 | MYLAN |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 202040 | TEVA PHARMS USA |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 206409 | ZYDUS PHARMS |
RELPAX | ELETRIPTAN HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021016 | UPJOHN |