Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 204026

Expand all

POMALYST (POMALIDOMIDE)
1MG
Marketing Status: Prescription

Active Ingredient: POMALIDOMIDE
Proprietary Name: POMALYST
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204026
Product Number: 001
Approval Date: Feb 8, 2013
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information

POMALYST (POMALIDOMIDE)
2MG
Marketing Status: Prescription

Active Ingredient: POMALIDOMIDE
Proprietary Name: POMALYST
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204026
Product Number: 002
Approval Date: Feb 8, 2013
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information

POMALYST (POMALIDOMIDE)
3MG
Marketing Status: Prescription

Active Ingredient: POMALIDOMIDE
Proprietary Name: POMALYST
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 3MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204026
Product Number: 003
Approval Date: Feb 8, 2013
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information

POMALYST (POMALIDOMIDE)
4MG
Marketing Status: Prescription

Active Ingredient: POMALIDOMIDE
Proprietary Name: POMALYST
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204026
Product Number: 004
Approval Date: Feb 8, 2013
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information