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AFREZZA
Insulin Human · Kit
Prescription Biologic BLA
Informational index, not medical advice. Content is reproduced from
public FDA and NLM data. Always confirm against the manufacturer's current
prescribing information.
Overview
Brand name
AFREZZA
Generic name
Insulin Human
Dosage form
Kit
Route
Respiratory (Inhalation)
Marketing category
BLA · BLA
Labeler
Mannkind Corporation
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
4
Packages
4
Data completeness
52%
of corroborating sources present
Forms, strengths and routes
Source: NDC DirectoryDosage form
Kit
Route of administration
Respiratory (Inhalation)
Presentations
8
Regulatory status
Source: Drugs@FDANDC DirectoryApplication number
022472
Application type
BLA · Biologics License Application
Approval date
June 27, 2014
Sponsor
MANNKIND
Products on application
3
Submissions recorded
15
| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 022472-001 | AFREZZA | POWDER | INSULIN RECOMBINANT HUMAN | Prescription | — | ||
| 022472-002 | AFREZZA | POWDER | INSULIN RECOMBINANT HUMAN | Prescription | — | ||
| 022472-003 | AFREZZA | POWDER | INSULIN RECOMBINANT HUMAN | Prescription | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 29 | Efficacy | Approved | May 29, 2026 | Standard |
| Supplement | 27 | Efficacy | Approved | January 23, 2026 | Standard |
| Supplement | 23 | Labeling | Approved | February 3, 2023 | Standard |
| Supplement | 18 | Labeling | Approved | October 25, 2018 | Standard |
| Supplement | 17 | REMS | Approved | April 24, 2018 | N/A |
| Supplement | 11 | Efficacy | Approved | September 29, 2017 | Standard |
| Supplement | 10 | Manufacturing (CMC) | Approved | April 7, 2016 | Standard |
| Supplement | 9 | Manufacturing (CMC) | Approved | February 17, 2016 | Standard |
| Supplement | 4 | Manufacturing (CMC) | Approved | September 16, 2015 | N/A |
| Supplement | 8 | Labeling | Approved | June 24, 2015 | Standard |
| Supplement | 6 | Manufacturing (CMC) | Approved | June 24, 2015 | Standard |
| Supplement | 2 | REMS | Approved | April 20, 2015 | N/A |
| Supplement | 3 | Manufacturing (CMC) | Approved | April 17, 2015 | Standard |
| Supplement | 5 | Labeling | Approved | March 12, 2015 | Standard |
| Original application | 1 | Type 5 - New Formulation or New Manufacturer | Approved | June 27, 2014 | Standard |
Review documents
- 0 · Supplement · June 2, 2026
- 0 · Supplement · June 1, 2026
- 0 · Supplement · June 1, 2026
- 0 · Supplement · January 28, 2026
- 0 · Supplement · January 26, 2026
- 0 · Supplement · January 26, 2026
- 0 · Supplement · February 6, 2023
- 0 · Supplement · February 6, 2023
- This Former NDA Was Deemed To Be a BLA on March 23, 2020. · Supplement · March 23, 2020
- This Former NDA Was Deemed To Be a BLA on March 23, 2020. · Supplement · March 23, 2020
- This Former NDA Was Deemed To Be a BLA on March 23, 2020. · Supplement · March 23, 2020
- This Former NDA Was Deemed To Be a BLA on March 23, 2020. · Supplement · March 23, 2020
- This Former NDA Was Deemed To Be a BLA on March 23, 2020. · Supplement · March 23, 2020
- This Former NDA Was Deemed To Be a BLA on March 23, 2020. · Supplement · March 23, 2020
- This Former NDA Was Deemed To Be a BLA on March 23, 2020. · Supplement · March 23, 2020
- This Former NDA Was Deemed To Be a BLA on March 23, 2020. · Supplement · March 23, 2020
- This Former NDA Was Deemed To Be a BLA on March 23, 2020. · Supplement · March 23, 2020
- 0 · Original application · March 23, 2020
- 0 · Original application · March 23, 2020
- This Former NDA Was Deemed To Be a BLA on March 23, 2020. · Supplement · March 23, 2020
- 0 · Original application · March 23, 2020
- This Former NDA Was Deemed To Be a BLA on March 23, 2020. · Supplement · March 23, 2020
- This Former NDA Was Deemed To Be a BLA on March 23, 2020. · Original application · March 23, 2020
- This Former NDA Was Deemed To Be a BLA on March 23, 2020. · Supplement · March 23, 2020
- This Former NDA Was Deemed To Be a BLA on March 23, 2020. · Supplement · March 23, 2020
- This Former NDA Was Deemed To Be a BLA on March 23, 2020. · Supplement · March 23, 2020
- 0 · Supplement · March 23, 2020
- 0 · Supplement · March 23, 2020
- This Former NDA Was Deemed To Be a BLA on March 23, 2020. · Appl · March 22, 2020
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 47918-880-18 | 47918-880 | Mannkind Corporation | 1 KIT in 1 CARTON (47918-880-18) * 3 POUCH in 1 PACKAGE, COMBINATION / 2 BLISTER PACK in 1 POUCH / 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE * 3 POUCH in 1 PACKAGE, COMBINATION / 2 BLISTER PACK in 1 POUCH / 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE | July 1, 2016 |
| 47918-898-18 | 47918-898 | Mannkind Corporation | 1 KIT in 1 CARTON (47918-898-18) * 3 POUCH in 1 PACKAGE, COMBINATION / 2 BLISTER PACK in 1 POUCH / 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE * 3 POUCH in 1 PACKAGE, COMBINATION / 2 BLISTER PACK in 1 POUCH / 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE | December 4, 2018 |
| 47918-902-18 | 47918-902 | Mannkind Corporation | 1 KIT in 1 CARTON (47918-902-18) * 2 POUCH in 1 PACKAGE, COMBINATION / 2 BLISTER PACK in 1 POUCH / 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE * 2 POUCH in 1 PACKAGE, COMBINATION / 2 BLISTER PACK in 1 POUCH / 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE * 2 POUCH in 1 PACKAGE, COMBINATION / 2 BLISTER PACK in 1 POUCH / 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE | January 10, 2017 |
| 47918-904-30 | 47918-904 | Mannkind Corporation | 1 KIT in 1 CARTON (47918-904-30) * 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE * 15 CARTRIDGE in 1 BLISTER PACK / 1 POWDER, METERED in 1 CARTRIDGE | June 1, 2025 |
| 47918-880 | 47918-880 | Mannkind Corporation | — | July 1, 2016 |
| 47918-898 | 47918-898 | Mannkind Corporation | — | December 4, 2018 |
| 47918-902 | 47918-902 | Mannkind Corporation | — | January 10, 2017 |
| 47918-904 | 47918-904 | Mannkind Corporation | — | June 1, 2025 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Purple Book | FDA | Biologic licence classification |
Generated September 25, 2026 · 7 sections on this page.