Drug Master Files for: METHOTREXATE

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METHOTREXATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
1057	I	II	5/2/1967	LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO	DICHLOROMETHOTREXATE
10863	I	II	4/5/1994	HEINRICH MACK NACHFOLGER	DISODIUM METHOTREXATE
11704	A	II	10/5/1995	EXCELLA GMBH AND CO KG	METHOTREXATE
12472	A	II	4/11/1997	EXCELLA GMBH AND CO KG	METHOTREXATE SODIUM
12833	I	II	1/30/1998	LIANYUNGANG PHARMACEUTICAL FACTORY	METHOTREXATE USP, NON-STERILE BULK DRUG
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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