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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200828
Company: IMPAX LABS INC

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
07/15/2013 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200828Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/29/2020 SUPPL-7 Labeling-Package Insert

Label is not available on this site.
01/29/2020 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
01/29/2020 SUPPL-4 Labeling-Package Insert

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 217278 ALEMBIC
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 200828 IMPAX LABS INC
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 214124 J MOLNER
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 204158 PH HEALTH
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 206382 SCIEGEN PHARMS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 219677 TARO
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 217100 TORRENT

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 217278 ALEMBIC
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 200828 IMPAX LABS INC
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 214124 J MOLNER
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 204158 PH HEALTH
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 206382 SCIEGEN PHARMS
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 219677 TARO
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 217100 TORRENT

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 217278 ALEMBIC
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 200828 IMPAX LABS INC
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 214124 J MOLNER
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 204158 PH HEALTH
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 206382 SCIEGEN PHARMS
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 219677 TARO
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 217100 TORRENT

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 217278 ALEMBIC
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 200828 IMPAX LABS INC
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 214124 J MOLNER
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 204158 PH HEALTH
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 206382 SCIEGEN PHARMS
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 219677 TARO
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 217100 TORRENT
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