Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020949

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ACCUNEB (ALBUTEROL SULFATE)
EQ 0.021% BASE Marketing Status: Prescription

Active Ingredient: ALBUTEROL SULFATE
Proprietary Name: ACCUNEB
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: EQ 0.021% BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AN
Application Number: N020949
Product Number: 002
Approval Date: Apr 30, 2001
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Prescription
Patent and Exclusivity Information

ACCUNEB (ALBUTEROL SULFATE)
EQ 0.042% BASE Marketing Status: Prescription

Active Ingredient: ALBUTEROL SULFATE
Proprietary Name: ACCUNEB
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: EQ 0.042% BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AN
Application Number: N020949
Product Number: 001
Approval Date: Apr 30, 2001
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Prescription
Patent and Exclusivity Information

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