Product Details for NDA 020837
XOPENEX (LEVALBUTEROL HYDROCHLORIDE)
EQ 0.0103% BASE
Marketing Status: Discontinued
EQ 0.021% BASE
Marketing Status: Discontinued
EQ 0.042% BASE
Marketing Status: Discontinued
EQ 0.25% BASE
Marketing Status: Discontinued
EQ 0.0103% BASE
Marketing Status: Discontinued
Active Ingredient: LEVALBUTEROL HYDROCHLORIDE
Proprietary Name: XOPENEX
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: EQ 0.0103% BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020837
Product Number: 003
Approval Date: Jan 30, 2002
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
XOPENEX (LEVALBUTEROL HYDROCHLORIDE)
Proprietary Name: XOPENEX
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: EQ 0.0103% BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020837
Product Number: 003
Approval Date: Jan 30, 2002
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 0.021% BASE
Marketing Status: Discontinued
Active Ingredient: LEVALBUTEROL HYDROCHLORIDE
Proprietary Name: XOPENEX
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: EQ 0.021% BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020837
Product Number: 001
Approval Date: Mar 25, 1999
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
XOPENEX (LEVALBUTEROL HYDROCHLORIDE)
Proprietary Name: XOPENEX
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: EQ 0.021% BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020837
Product Number: 001
Approval Date: Mar 25, 1999
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 0.042% BASE
Marketing Status: Discontinued
Active Ingredient: LEVALBUTEROL HYDROCHLORIDE
Proprietary Name: XOPENEX
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: EQ 0.042% BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020837
Product Number: 002
Approval Date: Mar 25, 1999
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
XOPENEX (LEVALBUTEROL HYDROCHLORIDE)
Proprietary Name: XOPENEX
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: EQ 0.042% BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020837
Product Number: 002
Approval Date: Mar 25, 1999
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 0.25% BASE
Marketing Status: Discontinued
Active Ingredient: LEVALBUTEROL HYDROCHLORIDE
Proprietary Name: XOPENEX
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: EQ 0.25% BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020837
Product Number: 004
Approval Date: Jul 18, 2003
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: XOPENEX
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: EQ 0.25% BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020837
Product Number: 004
Approval Date: Jul 18, 2003
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information