Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022472

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AFREZZA (INSULIN RECOMBINANT HUMAN)
4 UNITS/INH Marketing Status: Prescription

Active Ingredient: INSULIN RECOMBINANT HUMAN
Proprietary Name: AFREZZA
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 4 UNITS/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022472
Product Number: 001
Approval Date: Jun 27, 2014
Applicant Holder Full Name: MANNKIND CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

AFREZZA (INSULIN RECOMBINANT HUMAN)
8 UNITS/INH Marketing Status: Prescription

Active Ingredient: INSULIN RECOMBINANT HUMAN
Proprietary Name: AFREZZA
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 8 UNITS/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022472
Product Number: 002
Approval Date: Jun 27, 2014
Applicant Holder Full Name: MANNKIND CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

AFREZZA (INSULIN RECOMBINANT HUMAN)
12 UNITS/INH Marketing Status: Prescription

Active Ingredient: INSULIN RECOMBINANT HUMAN
Proprietary Name: AFREZZA
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 12 UNITS/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022472
Product Number: 003
Approval Date: Apr 17, 2015
Applicant Holder Full Name: MANNKIND CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

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