Last Updated: November 8, 2026

Drug Master Files for: TERBUTALINE SULFATE

TERBUTALINE SULFATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11927	A	II	4/17/1996	CAMBREX PROFARMACO MILANO SRL	TERBUTALINE SULFATE
26563	I	II	9/14/2012	MELODY HEALTHCARE PVT LTD	TERBUTALINE SULPHATE
4748	I	II	11/29/1982	COSMA SPA	TERBUTALINE SULPHATE
7942	I	II	3/1/1989	ASTRA PHARMACEUTICAL PRODUCTS INC	TERBUTALINE SULPHATE
8062	A	II	5/6/1989	CIPLA LTD	TERBUTALINE SULFATE USP
8117	I	II	6/26/1989	LUSOCHIMICA SPA	TERBUTALINE SULPHATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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