Drug Master Files for: Mannkind

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Mannkind Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16482	I	II	3/26/2003	MANNKIND CORP	INSULIN, HUMAN (RDNA HUMAN INSULIN) HMR 4006
28677	A	II	10/15/2014	MANNKIND CORP	AFREZZA? INHALATION POWDER AND AFREZZA? INHALER
33169	A	II	10/17/2018	MANNKIND CORP	TREPROSTINIL INHALATION POWDER
>DMF No.	>Status	>Type	>Submission Date	>Holder	>Subject

Drug Master File Glossary

STATUS OF DMFS

A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
I = Inactive
N = Not an assigned number
P = DMF Pending Filing Review

TYPES OF DMFs

Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III Packaging Material
Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V FDA Accepted Reference Information

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