Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 201452
Company: ARROW INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
05/21/2021 ORIG-2 Tentative Approval

Label is not available on this site.

05/21/2021 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201452Orig1s000TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/05/2021 SUPPL-1 REMS - MODIFIED - D-N-A

Label is not available on this site.

LENALIDOMIDE

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 201452 ARROW INTL
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 201452 ARROW INTL
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 201452 ARROW INTL
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 201452 ARROW INTL
REVLIMID LENALIDOMIDE 25MG CAPSULE;ORAL Prescription Yes AB 021880 CELGENE

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English