Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205523
Company: AJANTA PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALMOTRIPTAN MALATE ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET;ORAL Prescription AB No No
ALMOTRIPTAN MALATE ALMOTRIPTAN MALATE EQ 12.5MG 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
03/03/2016 ORIG-1 Approval STANDARD

Label is not available on this site.

ALMOTRIPTAN MALATE

TABLET;ORAL; EQ 6.25MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALMOTRIPTAN MALATE ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET;ORAL Prescription No AB 205523 AJANTA PHARMA LTD
ALMOTRIPTAN MALATE ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET;ORAL Prescription No AB 205171 MYLAN PHARMS INC
ALMOTRIPTAN MALATE ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET;ORAL Prescription No AB 078027 TEVA PHARMS USA
AXERT ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET;ORAL Prescription Yes AB 021001 JANSSEN PHARMS

TABLET;ORAL; EQ 12.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALMOTRIPTAN MALATE ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET;ORAL Prescription No AB 205523 AJANTA PHARMA LTD
ALMOTRIPTAN MALATE ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET;ORAL Prescription No AB 205171 MYLAN PHARMS INC
ALMOTRIPTAN MALATE ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET;ORAL Prescription No AB 078027 TEVA PHARMS USA
AXERT ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET;ORAL Prescription Yes AB 021001 JANSSEN PHARMS

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