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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077526
Company: CELLTRION
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
03/26/2013 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
01/29/2020 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

11/27/2015 SUPPL-1 Labeling-Container/Carton Labels, 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 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 PHARMGEN
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 ORGANON LLC
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 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 PHARMGEN
RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET;ORAL Prescription No AB 077263 TEVA PHARMS
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