Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211238
Company: DR REDDYS LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 200MG TABLET;ORAL Prescription AB No No
ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 400MG TABLET;ORAL Prescription AB No No
ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 600MG TABLET;ORAL Prescription AB No No
ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 800MG TABLET;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
06/29/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211238Orig1s000ltr.pdf

ESLICARBAZEPINE ACETATE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APTIOM ESLICARBAZEPINE ACETATE 200MG TABLET;ORAL Prescription Yes AB 022416 SUNOVION PHARMS INC
ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 200MG TABLET;ORAL Prescription No AB 211238 DR REDDYS LABS LTD

TABLET;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APTIOM ESLICARBAZEPINE ACETATE 400MG TABLET;ORAL Prescription Yes AB 022416 SUNOVION PHARMS INC
ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 400MG TABLET;ORAL Prescription No AB 211238 DR REDDYS LABS LTD

TABLET;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APTIOM ESLICARBAZEPINE ACETATE 600MG TABLET;ORAL Prescription Yes AB 022416 SUNOVION PHARMS INC
ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 600MG TABLET;ORAL Prescription No AB 211238 DR REDDYS LABS LTD

TABLET;ORAL; 800MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APTIOM ESLICARBAZEPINE ACETATE 800MG TABLET;ORAL Prescription Yes AB 022416 SUNOVION PHARMS INC
ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 800MG TABLET;ORAL Prescription No AB 211238 DR REDDYS LABS LTD

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