Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204722
Company: PANACEA BIOTEC 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
01/11/2017 ORIG-1 Approval

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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