Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204158
Company: PAR PHARM
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
10/27/2015 ORIG-1 Approval

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 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 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 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 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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