Drug Master Files for: terbinafine hydrochloride

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terbinafine hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15887	A	II	3/6/2002	DR REDDYS LABORATORIES LTD	TERBINAFINE HYDROCHLORIDE USP
16187	A	II	10/4/2002	UQUIFA MEXICO SA DE CV	TERBINAFINE HYDROCHLORIDE
16283	A	II	11/28/2002	AMINO CHEMICALS LTD	TERBINAFINE HYDROCHLORIDE
16511	A	II	3/26/2003	GEDEON RICHTER PLC	TERBINAFINE HYDROCHLORIDE USP
16784	I	II	8/20/2003	PERRIGO API LTD	TERBINAFINE HYDROCHLORIDE
17291	I	II	3/19/2004	RECORDATI ESPANA SL	TERBINAFINE HYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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