Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020837

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XOPENEX (LEVALBUTEROL HYDROCHLORIDE)
EQ 0.0103% BASE Marketing Status: Prescription

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: Yes
TE Code: AN
Application Number: N020837
Product Number: 003
Approval Date: Jan 30, 2002
Applicant Holder Full Name: OAK PHARMACEUTICALS INC SUBSIDIARY OF AKORN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XOPENEX (LEVALBUTEROL HYDROCHLORIDE)
EQ 0.021% BASE Marketing Status: Prescription

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: Yes
TE Code: AN
Application Number: N020837
Product Number: 001
Approval Date: Mar 25, 1999
Applicant Holder Full Name: OAK PHARMACEUTICALS INC SUBSIDIARY OF AKORN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XOPENEX (LEVALBUTEROL HYDROCHLORIDE)
EQ 0.042% BASE Marketing Status: Prescription

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: Yes
TE Code: AN
Application Number: N020837
Product Number: 002
Approval Date: Mar 25, 1999
Applicant Holder Full Name: OAK PHARMACEUTICALS INC SUBSIDIARY OF AKORN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XOPENEX (LEVALBUTEROL HYDROCHLORIDE)
EQ 0.25% BASE Marketing Status: Prescription

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: Yes
TE Code: AN
Application Number: N020837
Product Number: 004
Approval Date: Jul 18, 2003
Applicant Holder Full Name: OAK PHARMACEUTICALS INC SUBSIDIARY OF AKORN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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