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Details for New Drug Application (NDA): 020785

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NDA 020785 describes THALOMID, which is a drug marketed by Celgene and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug and three Paragraph IV challenges. Additional details are available on the THALOMID profile page.

The generic ingredient in THALOMID is thalidomide. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the thalidomide profile page.

Summary for 020785

Tradename:	THALOMID
Applicant:	Celgene
Ingredient:	thalidomide
Patents:	15
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020785

Physiological Effect

Decreased Immunologically Active Molecule Activity

Medical Subject Heading (MeSH) Categories for 020785

Angiogenesis Inhibitors

Immunosuppressive Agents

Leprostatic Agents

Teratogens

Suppliers and Packaging for NDA: 020785

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
THALOMID	thalidomide	CAPSULE;ORAL	020785	NDA	Celgene Corporation	59572-205	59572-205-94	10 BLISTER PACK in 1 BOX (59572-205-94) > 28 CAPSULE in 1 BLISTER PACK (59572-205-14)
THALOMID	thalidomide	CAPSULE;ORAL	020785	NDA	Celgene Corporation	59572-205	59572-205-97	10 BLISTER PACK in 1 BOX (59572-205-97) > 1 CAPSULE in 1 BLISTER PACK (59572-205-17)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Jul 16, 1998	TE:		RLD:	Yes
Patent:		Patent Expiration:	Aug 28, 2018	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)
Patent:		Patent Expiration:	Aug 28, 2018	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
Patent:		Patent Expiration:	Oct 23, 2020	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD FOR DELIVERING A DRUG TO A PATIENT IN NEED OF THE DRUG, WHILE AVOIDING THE OCCURRENCE OF AN ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY SAID DRUG

Expired US Patents for NDA 020785

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003

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