Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213271
Company: AJANTA PHARMA LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
LAMOTRIGINE LAMOTRIGINE 200MG 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
01/19/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

LAMOTRIGINE

TABLET, ORALLY DISINTEGRATING;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL ODT LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 022251 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 213271 AJANTA PHARMA LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 200828 IMPAX LABS INC
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 204158 PAR PHARM
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 206382 SCIEGEN PHARMS INC

TABLET, ORALLY DISINTEGRATING;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL ODT LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 022251 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 213271 AJANTA PHARMA LTD
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 200828 IMPAX LABS INC
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 204158 PAR PHARM
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 206382 SCIEGEN PHARMS INC

TABLET, ORALLY DISINTEGRATING;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL ODT LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 022251 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 213271 AJANTA PHARMA LTD
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 200828 IMPAX LABS INC
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 204158 PAR PHARM
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 206382 SCIEGEN PHARMS INC

TABLET, ORALLY DISINTEGRATING;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL ODT LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 022251 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 213271 AJANTA PHARMA LTD
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 200828 IMPAX LABS INC
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 204158 PAR PHARM
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 206382 SCIEGEN PHARMS INC

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