Drug Master Files for: ALCAFTADINE

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ALCAFTADINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
20066	A	II	12/21/2006	CILAG AG	ALCAFTADINE (R89674) DRUG SUBSTANCE
27559	I	II	12/21/2013	ENALTEC LABS PRIVATE LTD	ALCAFTADINE
27982	A	II	2/18/2014	CRYSTAL PHARMA SAU	ALCAFTADINE
28277	A	II	5/8/2014	NEULAND LABORATORIES LTD	ALCAFTADINE
28932	A	II	2/4/2015	MSN LABORATORIES PRIVATE LTD	ALCAFTADINE [ROUTE CODE FA]
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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