Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201374
Company: ANCHEN PHARMS
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
12/26/2012 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/201374Orig1s000Approv.pdf

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 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 202887 HANDA PHARMS LLC
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 PHARMS LTD
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 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 202887 HANDA PHARMS LLC
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 PHARMS LTD
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 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 202887 HANDA PHARMS LLC
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201791 PAR PHARM
LAMOTRIGINE LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203370 TORRENT PHARMS LTD
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 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 202887 HANDA PHARMS LLC
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201791 PAR PHARM
LAMOTRIGINE LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203370 TORRENT PHARMS LTD
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 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 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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