Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201791
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
LAMOTRIGINE LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
LAMOTRIGINE LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE;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
01/18/2013 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
06/19/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

06/19/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

06/19/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

04/24/2014 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

LAMOTRIGINE

TABLET, EXTENDED RELEASE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL XR LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022115 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200672 ACTAVIS ELIZABETH
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207497 AMNEAL PHARMS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201374 ANCHEN PHARMS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202383 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201791 PAR PHARM
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203370 TORRENT
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202498 WOCKHARDT LTD

TABLET, EXTENDED RELEASE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL XR LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022115 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200672 ACTAVIS ELIZABETH
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207497 AMNEAL PHARMS
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201374 ANCHEN PHARMS
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202383 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201791 PAR PHARM
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203370 TORRENT
LAMOTRIGINE LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202498 WOCKHARDT LTD

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL XR LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022115 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200672 ACTAVIS ELIZABETH
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207497 AMNEAL PHARMS
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201374 ANCHEN PHARMS
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202383 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201791 PAR PHARM
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202887 RUBICON
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203370 TORRENT
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202498 WOCKHARDT LTD

TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL XR LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022115 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200672 ACTAVIS ELIZABETH
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207497 AMNEAL PHARMS
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201374 ANCHEN PHARMS
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202383 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201791 PAR PHARM
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202887 RUBICON
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203370 TORRENT
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202498 WOCKHARDT LTD

TABLET, EXTENDED RELEASE;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL XR LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022115 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203733 ACTAVIS ELIZABETH
LAMOTRIGINE LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207497 AMNEAL PHARMS
LAMOTRIGINE LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201374 ANCHEN PHARMS
LAMOTRIGINE LAMOTRIGINE 250MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201791 PAR PHARM

TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL XR LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022115 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200672 ACTAVIS ELIZABETH
LAMOTRIGINE LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207497 AMNEAL PHARMS
LAMOTRIGINE LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201374 ANCHEN PHARMS
LAMOTRIGINE LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202383 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201791 PAR PHARM
LAMOTRIGINE LAMOTRIGINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202498 WOCKHARDT LTD

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