Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078009
Company: ZYDUS PHARMS USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMOTRIGINE LAMOTRIGINE 2MG TABLET, CHEWABLE; ORAL Prescription None No No
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription AB No No
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;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
01/22/2009 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078009Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/11/2015 SUPPL-19 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/11/2015 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/11/2015 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/11/2015 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/26/2014 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

09/26/2014 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

09/26/2014 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

03/14/2012 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

03/14/2012 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

03/07/2012 SUPPL-7 REMS-Modified

Label is not available on this site.

09/29/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

04/25/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

06/23/2010 SUPPL-4 Labeling-Container/Carton Labels

Label is not available on this site.

06/23/2010 SUPPL-3 Labeling-Medication Guide, REMS-Proposal

Label is not available on this site.

06/23/2010 SUPPL-1 Labeling

Label is not available on this site.

LAMOTRIGINE

TABLET, CHEWABLE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL CD LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription Yes AB 020764 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 201168 ALEMBIC PHARMS LTD
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 090401 AUROBINDO PHARMA
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 076701 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 079099 GLENMARK PHARMS LTD
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 200220 JUBILANT GENERICS
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 079204 TARO
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 076420 TEVA
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 076928 WATSON LABS
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Prescription No AB 078009 ZYDUS PHARMS USA INC

TABLET, CHEWABLE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMICTAL CD LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription Yes AB 020764 GLAXOSMITHKLINE LLC
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 201168 ALEMBIC PHARMS LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 090401 AUROBINDO PHARMA
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 076701 DR REDDYS LABS LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 079099 GLENMARK PHARMS LTD
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 200220 JUBILANT GENERICS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 079204 TARO
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 076420 TEVA
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 076928 WATSON LABS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;ORAL Prescription No AB 078009 ZYDUS PHARMS USA INC

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