Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090297

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

Active Ingredient: LEVALBUTEROL HYDROCHLORIDE
Proprietary Name: LEVALBUTEROL HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: EQ 0.0103% BASE
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AN
Application Number: A090297
Product Number: 001
Approval Date: Apr 26, 2013
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: LEVALBUTEROL HYDROCHLORIDE
Proprietary Name: LEVALBUTEROL HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: EQ 0.021% BASE
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AN
Application Number: A090297
Product Number: 002
Approval Date: Apr 26, 2013
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: LEVALBUTEROL HYDROCHLORIDE
Proprietary Name: LEVALBUTEROL HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: EQ 0.042% BASE
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AN
Application Number: A090297
Product Number: 003
Approval Date: Apr 26, 2013
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information