Drug Master Files for: hydrocodone bitartrate

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hydrocodone bitartrate Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12025	I	II	7/3/1996	WATSON LABORATORIES INC	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, 10 MG\650 MG
12029	I	II	7/3/1996	WATSON LABORATORIES INC	HYDROCODONE BITARTRATE TABLETS, 10 MG
12848	A	II	2/5/1998	JOHNSON MATTHEY PHARMACEUTICAL MATERIALS	HYDROCODONE BITARTRATE, USP
16102	I	II	8/19/2002	MALLINCKRODT INC	HYDROCODONE ALKALOID
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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