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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205636

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PROAIR RESPICLICK (ALBUTEROL SULFATE)
EQ 0.09MG BASE/INH
Marketing Status: Prescription
Active Ingredient: ALBUTEROL SULFATE
Proprietary Name: PROAIR RESPICLICK
Dosage Form; Route of Administration: POWDER, METERED; INHALATION
Strength: EQ 0.09MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205636
Product Number: 001
Approval Date: Mar 31, 2015
Applicant Holder Full Name: TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PROAIR DIGIHALER (ALBUTEROL SULFATE)
EQ 0.09MG BASE/INH
Marketing Status: Discontinued
Active Ingredient: ALBUTEROL SULFATE
Proprietary Name: PROAIR DIGIHALER
Dosage Form; Route of Administration: POWDER, METERED; INHALATION
Strength: EQ 0.09MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205636
Product Number: 002
Approval Date: Dec 21, 2018
Applicant Holder Full Name: TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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