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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 214531

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ALBUTEROL SULFATE (ALBUTEROL SULFATE)
EQ 0.021% BASE
Marketing Status: Prescription
Active Ingredient: ALBUTEROL SULFATE
Proprietary Name: ALBUTEROL SULFATE
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: EQ 0.021% BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AN
Application Number: A214531
Product Number: 001
Approval Date: Dec 28, 2021
Applicant Holder Full Name: THE RITEDOSE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
ALBUTEROL SULFATE (ALBUTEROL SULFATE)
EQ 0.042% BASE
Marketing Status: Prescription
Active Ingredient: ALBUTEROL SULFATE
Proprietary Name: ALBUTEROL SULFATE
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: EQ 0.042% BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AN
Application Number: A214531
Product Number: 002
Approval Date: Dec 28, 2021
Applicant Holder Full Name: THE RITEDOSE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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