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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209348
Company: DR REDDYS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LENALIDOMIDE LENALIDOMIDE 2.5MG CAPSULE;ORAL Prescription AB No No
LENALIDOMIDE LENALIDOMIDE 20MG CAPSULE;ORAL Prescription AB No No
LENALIDOMIDE LENALIDOMIDE 5MG CAPSULE;ORAL Prescription AB No No
LENALIDOMIDE LENALIDOMIDE 10MG CAPSULE;ORAL Prescription AB No No
LENALIDOMIDE LENALIDOMIDE 15MG CAPSULE;ORAL Prescription AB No No
LENALIDOMIDE LENALIDOMIDE 25MG CAPSULE;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
08/30/2022 ORIG-2 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209348Orig1s000ltr, 209348Orig2s000TAltr.pdf
10/14/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209348Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/07/2022 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

06/30/2022 SUPPL-1 REMS - MODIFIED - D-N-A

Label is not available on this site.

LENALIDOMIDE

CAPSULE;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LENALIDOMIDE LENALIDOMIDE 2.5MG CAPSULE;ORAL Prescription No AB 209348 DR REDDYS
REVLIMID LENALIDOMIDE 2.5MG CAPSULE;ORAL Prescription Yes AB 021880 CELGENE

CAPSULE;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LENALIDOMIDE LENALIDOMIDE 20MG CAPSULE;ORAL Prescription No AB 209348 DR REDDYS
REVLIMID LENALIDOMIDE 20MG CAPSULE;ORAL Prescription Yes AB 021880 CELGENE

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LENALIDOMIDE LENALIDOMIDE 5MG CAPSULE;ORAL Prescription No AB 211022 APOTEX
LENALIDOMIDE LENALIDOMIDE 5MG CAPSULE;ORAL Prescription No AB 201452 ARROW INTL
LENALIDOMIDE LENALIDOMIDE 5MG CAPSULE;ORAL Prescription No AB 210435 CIPLA
LENALIDOMIDE LENALIDOMIDE 5MG CAPSULE;ORAL Prescription No AB 209348 DR REDDYS
LENALIDOMIDE LENALIDOMIDE 5MG CAPSULE;ORAL Prescription No AB 210480 LOTUS PHARM CO LTD
LENALIDOMIDE LENALIDOMIDE 5MG CAPSULE;ORAL Prescription No AB 213912 MYLAN
LENALIDOMIDE LENALIDOMIDE 5MG CAPSULE;ORAL Prescription No AB 210154 ZYDUS PHARMS
REVLIMID LENALIDOMIDE 5MG CAPSULE;ORAL Prescription Yes AB 021880 CELGENE

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LENALIDOMIDE LENALIDOMIDE 10MG CAPSULE;ORAL Prescription No AB 211022 APOTEX
LENALIDOMIDE LENALIDOMIDE 10MG CAPSULE;ORAL Prescription No AB 201452 ARROW INTL
LENALIDOMIDE LENALIDOMIDE 10MG CAPSULE;ORAL Prescription No AB 210435 CIPLA
LENALIDOMIDE LENALIDOMIDE 10MG CAPSULE;ORAL Prescription No AB 209348 DR REDDYS
LENALIDOMIDE LENALIDOMIDE 10MG CAPSULE;ORAL Prescription No AB 210480 LOTUS PHARM CO LTD
LENALIDOMIDE LENALIDOMIDE 10MG CAPSULE;ORAL Prescription No AB 213912 MYLAN
LENALIDOMIDE LENALIDOMIDE 10MG CAPSULE;ORAL Prescription No AB 210154 ZYDUS PHARMS
REVLIMID LENALIDOMIDE 10MG CAPSULE;ORAL Prescription Yes AB 021880 CELGENE

CAPSULE;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LENALIDOMIDE LENALIDOMIDE 15MG CAPSULE;ORAL Prescription No AB 211022 APOTEX
LENALIDOMIDE LENALIDOMIDE 15MG CAPSULE;ORAL Prescription No AB 201452 ARROW INTL
LENALIDOMIDE LENALIDOMIDE 15MG CAPSULE;ORAL Prescription No AB 210435 CIPLA
LENALIDOMIDE LENALIDOMIDE 15MG CAPSULE;ORAL Prescription No AB 209348 DR REDDYS
LENALIDOMIDE LENALIDOMIDE 15MG CAPSULE;ORAL Prescription No AB 210480 LOTUS PHARM CO LTD
LENALIDOMIDE LENALIDOMIDE 15MG CAPSULE;ORAL Prescription No AB 213912 MYLAN
LENALIDOMIDE LENALIDOMIDE 15MG CAPSULE;ORAL Prescription No AB 210154 ZYDUS PHARMS
REVLIMID LENALIDOMIDE 15MG CAPSULE;ORAL Prescription Yes AB 021880 CELGENE

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LENALIDOMIDE LENALIDOMIDE 25MG CAPSULE;ORAL Prescription No AB 211022 APOTEX
LENALIDOMIDE LENALIDOMIDE 25MG CAPSULE;ORAL Prescription No AB 201452 ARROW INTL
LENALIDOMIDE LENALIDOMIDE 25MG CAPSULE;ORAL Prescription No AB 210435 CIPLA
LENALIDOMIDE LENALIDOMIDE 25MG CAPSULE;ORAL Prescription No AB 209348 DR REDDYS
LENALIDOMIDE LENALIDOMIDE 25MG CAPSULE;ORAL Prescription No AB 210480 LOTUS PHARM CO LTD
LENALIDOMIDE LENALIDOMIDE 25MG CAPSULE;ORAL Prescription No AB 213912 MYLAN
LENALIDOMIDE LENALIDOMIDE 25MG CAPSULE;ORAL Prescription No AB 210154 ZYDUS PHARMS
REVLIMID LENALIDOMIDE 25MG CAPSULE;ORAL Prescription Yes AB 021880 CELGENE
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