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Abbreviated New Drug Application (ANDA): 203146
Company: MACLEODS PHARMS 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
09/19/2014 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203146Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/29/2019 SUPPL-17 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 203146 MACLEODS PHARMS LTD
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
RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 207835 UNICHEM

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 ORGANON
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 203146 MACLEODS PHARMS LTD
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
RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 207835 UNICHEM
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