Drug Master Files for: TERIPARATIDE ACETATE

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TERIPARATIDE ACETATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
28464	A	II	6/1/2017	AMBIOPHARM INC	TERIPARATIDE USP (ACETATE FORM)
29079	I	II	2/24/2015	TEVA PHARMACEUTICAL INDUSTRIES LTD	TERIPARATIDE ACETATE
29122	A	II	4/1/2015	RICHTER-HELM BIOTEC GMBH AND CO KG	TERIPARATIDE
33079	A	II	8/17/2018	AURO PEPTIDES LTD	TERIPARATIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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