Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020785

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THALOMID (THALIDOMIDE)
50MG
Marketing Status: Prescription

Active Ingredient: THALIDOMIDE
Proprietary Name: THALOMID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020785
Product Number: 001
Approval Date: Jul 16, 1998
Applicant Holder Full Name: BRISTOL-MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information

THALOMID (THALIDOMIDE)
100MG
Marketing Status: Prescription

Active Ingredient: THALIDOMIDE
Proprietary Name: THALOMID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020785
Product Number: 002
Approval Date: Jan 17, 2003
Applicant Holder Full Name: BRISTOL-MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information

THALOMID (THALIDOMIDE)
150MG
Marketing Status: Prescription

Active Ingredient: THALIDOMIDE
Proprietary Name: THALOMID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020785
Product Number: 004
Approval Date: Jan 10, 2007
Applicant Holder Full Name: BRISTOL-MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information

THALOMID (THALIDOMIDE)
200MG
Marketing Status: Prescription

Active Ingredient: THALIDOMIDE
Proprietary Name: THALOMID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020785
Product Number: 003
Approval Date: Jan 17, 2003
Applicant Holder Full Name: BRISTOL-MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information