Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 210111

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POMALIDOMIDE (POMALIDOMIDE)
1MG
Marketing Status: Discontinued

Active Ingredient: POMALIDOMIDE
Proprietary Name: POMALIDOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A210111
Product Number: 001
Approval Date: Oct 30, 2020
Applicant Holder Full Name: BRECKENRIDGE PHARMACEUTICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

POMALIDOMIDE (POMALIDOMIDE)
2MG
Marketing Status: Discontinued

Active Ingredient: POMALIDOMIDE
Proprietary Name: POMALIDOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A210111
Product Number: 002
Approval Date: Oct 30, 2020
Applicant Holder Full Name: BRECKENRIDGE PHARMACEUTICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

POMALIDOMIDE (POMALIDOMIDE)
3MG
Marketing Status: Discontinued

Active Ingredient: POMALIDOMIDE
Proprietary Name: POMALIDOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 3MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A210111
Product Number: 003
Approval Date: Oct 30, 2020
Applicant Holder Full Name: BRECKENRIDGE PHARMACEUTICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

POMALIDOMIDE (POMALIDOMIDE)
4MG
Marketing Status: Discontinued

Active Ingredient: POMALIDOMIDE
Proprietary Name: POMALIDOMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A210111
Product Number: 004
Approval Date: Oct 30, 2020
Applicant Holder Full Name: BRECKENRIDGE PHARMACEUTICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information