Application 022472

Type: BLA
Sponsor: MANNKIND

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
022472	Afrezza	insulin human	351(a)	Rx	2026-07-01

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AFREZZA	INSULIN RECOMBINANT HUMAN	POWDER;INHALATION	4 UNITS/INH	No	No
002	AFREZZA	INSULIN RECOMBINANT HUMAN	POWDER;INHALATION	8 UNITS/INH	No	No
003	AFREZZA	INSULIN RECOMBINANT HUMAN	POWDER;INHALATION	12 UNITS/INH	No	No

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AFREZZA	INSULIN HUMAN	Mannkind Corporation	29f4637b-e204-425b-b89c-7238008d8c10	2026-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA022472 ndc (product): 47918-880 ndc (product): 47918-878 ndc (product): 47918-891 ndc (product): 47918-902 ndc (product): 47918-874 ndc (product): 47918-898

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47918-874	Afrezza	Insulin Human	Mannkind Corporation	BLA	Current
47918-874	Afrezza	Insulin Human	Mannkind Corporation	BLA	Current
47918-874	Afrezza	Insulin Human	Mannkind Corporation	NDA	Current
47918-874	Afrezza	Insulin Human	Mannkind Corporation	BLA	Current
47918-874	Afrezza	Insulin Human	Mannkind Corporation	NDA	Current
47918-878	Afrezza	Insulin Human	Mannkind Corporation	BLA	Current
47918-878	Afrezza	Insulin Human	Mannkind Corporation	BLA	Current
47918-878	Afrezza	Insulin Human	Mannkind Corporation	NDA	Current
47918-878	Afrezza	Insulin Human	Mannkind Corporation	BLA	Current
47918-878	Afrezza	Insulin Human	Mannkind Corporation	NDA	Current
47918-880	Afrezza	Insulin Human	Mannkind Corporation	BLA	Current
47918-880	Afrezza	Insulin Human	Mannkind Corporation	BLA	Current
47918-880	Afrezza	Insulin Human	Mannkind Corporation	NDA	Current
47918-880	Afrezza	Insulin Human	Mannkind Corporation	BLA	Current
47918-880	Afrezza	Insulin Human	Mannkind Corporation	NDA	Current
47918-882	Afrezza	Insulin Human	Mannkind Corporation	NDA	Current
47918-891	Afrezza	Insulin Human	Mannkind Corporation	BLA	Current
47918-891	Afrezza	Insulin Human	Mannkind Corporation	BLA	Current
47918-891	Afrezza	Insulin Human	Mannkind Corporation	NDA	Current
47918-891	Afrezza	Insulin Human	Mannkind Corporation	BLA	Current
47918-891	Afrezza	Insulin Human	Mannkind Corporation	NDA	Current
47918-894	Afrezza	Insulin Human	Mannkind Corporation	NDA	Current
47918-898	Afrezza	Insulin Human	Mannkind Corporation	BLA	Current
47918-898	Afrezza	Insulin Human	Mannkind Corporation	BLA	Current
47918-898	Afrezza	Insulin Human	Mannkind Corporation	NDA	Current
47918-898	Afrezza	Insulin Human	Mannkind Corporation	BLA	Current
47918-898	Afrezza	Insulin Human	Mannkind Corporation	NDA	Current
47918-902	Afrezza	Insulin Human	Mannkind Corporation	BLA	Current
47918-902	Afrezza	Insulin Human	Mannkind Corporation	BLA	Current
47918-902	Afrezza	Insulin Human	Mannkind Corporation	NDA	Current
47918-902	Afrezza	Insulin Human	Mannkind Corporation	BLA	Current
47918-902	Afrezza	Insulin Human	Mannkind Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84845	SUPPL	2026-01-28
84844	SUPPL	2026-01-28
84837	SUPPL	2026-01-26
84836	SUPPL	2026-01-26
73386	SUPPL	2023-02-06
73381	SUPPL	2023-02-06
56144	SUPPL	2020-03-23
56111	SUPPL	2020-03-23
53810	SUPPL	2020-03-23
49923	SUPPL	2020-03-23
49905	SUPPL	2020-03-23
49904	SUPPL	2020-03-23
44759	ORIG	2020-03-23
44505	ORIG	2020-03-23
38748	SUPPL	2020-03-23
38747	ORIG	2020-03-23
29765	SUPPL	2020-03-23
29764	ORIG	2020-03-23
22030	ORIG	2020-03-23
17627	SUPPL	2020-03-23
17626	SUPPL	2020-03-23
17625	SUPPL	2020-03-23
17624	SUPPL	2020-03-23
17623	SUPPL	2020-03-23
17622	SUPPL	2020-03-23
7440	SUPPL	2020-03-23
7439	SUPPL	2020-03-23
7438	SUPPL	2020-03-23
66368	APPL	2020-03-22