Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210249
Company: EUGIA PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POMALIDOMIDE POMALIDOMIDE 1MG CAPSULE;ORAL Prescription AB No No
POMALIDOMIDE POMALIDOMIDE 2MG CAPSULE;ORAL Prescription AB No No
POMALIDOMIDE POMALIDOMIDE 3MG CAPSULE;ORAL Prescription AB No No
POMALIDOMIDE POMALIDOMIDE 4MG 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
10/30/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210249Orig1s000ltr.pdf

POMALIDOMIDE

CAPSULE;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POMALIDOMIDE POMALIDOMIDE 1MG CAPSULE;ORAL Prescription No AB 210111 BRECKENRIDGE
POMALIDOMIDE POMALIDOMIDE 1MG CAPSULE;ORAL Prescription No AB 210249 EUGIA PHARMA
POMALYST POMALIDOMIDE 1MG CAPSULE;ORAL Prescription Yes AB 204026 CELGENE

CAPSULE;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POMALIDOMIDE POMALIDOMIDE 2MG CAPSULE;ORAL Prescription No AB 210111 BRECKENRIDGE
POMALIDOMIDE POMALIDOMIDE 2MG CAPSULE;ORAL Prescription No AB 210249 EUGIA PHARMA
POMALYST POMALIDOMIDE 2MG CAPSULE;ORAL Prescription Yes AB 204026 CELGENE

CAPSULE;ORAL; 3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POMALIDOMIDE POMALIDOMIDE 3MG CAPSULE;ORAL Prescription No AB 210111 BRECKENRIDGE
POMALIDOMIDE POMALIDOMIDE 3MG CAPSULE;ORAL Prescription No AB 210249 EUGIA PHARMA
POMALYST POMALIDOMIDE 3MG CAPSULE;ORAL Prescription Yes AB 204026 CELGENE

CAPSULE;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POMALIDOMIDE POMALIDOMIDE 4MG CAPSULE;ORAL Prescription No AB 210111 BRECKENRIDGE
POMALIDOMIDE POMALIDOMIDE 4MG CAPSULE;ORAL Prescription No AB 210249 EUGIA PHARMA
POMALYST POMALIDOMIDE 4MG CAPSULE;ORAL Prescription Yes AB 204026 CELGENE

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