Viewing data from:

Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

THALOMID

NDANot in Orange Book

THALIDOMIDE | N021430 | CELGENE

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs6 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

OLON SPATHALIDOMIDE

DMF 184482005

HETERO LABS LTDTHALIDOMIDE USP

DMF 197452006

LAURUS LABS LTDTHALIDOMIDE USP

DMF 279672014

SHILPA PHARMA LIFESCIENCES LTDTHALIDOMIDE USP

DMF 330882018

ANDRULIS PHARMACEUTICALS CORPInactiveTHALIDOMIDE

DMF 82631989

PEDIATRIC PHARMACEUTICALS INCInactiveTHALIDOMIDE TABLETS

DMF 97681992

SIFAVITOR SPAInactiveTHALIDOMIDE

DMF 152912001

FIS FABBRICA ITALIANA SINTETICI SPAInactiveTHALIDOMIDE

DMF 218062008

DR REDDYS LABORATORIES LTDInactiveTHALIDOMIDE

DMF 226782009

MYLAN LABORATORIES LTDInactiveTHALIDOMIDE USP

DMF 294522015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 26, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 50MG

▴

CAPSULE; ORAL | Approved: May. 25, 2006

No patent or exclusivity listings for this strength.

#002 — 100MG

▾

CAPSULE; ORAL | Approved: May. 25, 2006

#003 — 200MG

▾

CAPSULE; ORAL | Approved: May. 25, 2006