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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 sixteen 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 nine 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 NDA: 020785

Tradename:
THALOMID
Applicant:
Celgene
Ingredient:
thalidomide
Patents:16
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 020785

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jul 16, 1998TE:RLD:No
Patent:7,230,012Patent Expiration:Dec 9, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:6,869,399Patent Expiration:Oct 23, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA NODOSUM LEPROSUM (ENL)
Patent:7,141,018Patent Expiration:Oct 23, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA NODOSUM LEPROSUM (ENL)

Expired Orange Book Patents for NDA: 020785

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-002Jan 17, 20037,723,361► subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-004Jan 10, 20075,629,327► subscribe
Celgene
THALOMID
thalidomide
CAPSULE;ORAL020785-004Jan 10, 20076,235,756► subscribe
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