Details for New Drug Application (NDA): 020785

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NDA 020785 describes THALOMID, which is a drug marketed by Bristol-myers and is included in one NDA. It is available from one supplier. 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:	Bristol-myers
Ingredient:	thalidomide
Patents:	0

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

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Jan 17, 2003	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Jan 17, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 020785

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998	8,589,188	⤷ Get Started Free
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998	8,204,763	⤷ Get Started Free
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003	6,315,720	⤷ Get Started Free
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-003	Jan 17, 2003	8,143,283	⤷ Get Started Free
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998	6,755,784	⤷ Get Started Free
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003	5,629,327	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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