Drug Master Files for: Otsuka
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Otsuka Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10257 | I | II | 5/20/1993 | OTSUKA PHARMACEUTICAL CO LTD | FORMULATION RESEARCH INSTITUTE IN TOKUSHIMA, JAPAN |
12418 | I | II | 3/1/1997 | OTSUKA PHARMACEUTICAL CO LTD | NADIFLOXACIN DRUG SUBSTANCE |
13285 | I | II | 10/15/1998 | OTSUKA PHARMACEUTICAL CO LTD | NO-1886 DRUG SUBSTANCE |
15001 | I | II | 8/10/2000 | OTSUKA PHARMACEUTICAL CO LTD | REBAMIPIDE(OPC-12759) DRUG SUBSTANCE |
20451 | I | II | 4/10/2007 | OTSUKA CHEMICAL CO LTD | P-METHOXYBENZYL(6R,7R)-3-CHLOROMETHYL-8-OXO-7-PHENYLACETAMIDO-5-THIA-1-AZABICYCLO [4.2.0]OCT-2-ENE-2-CARBOXYLATE, GCLE |
22722 | A | II | 4/13/2009 | OTSUKA CHEMICAL INDIA PRIVATE LTD | P-METHOXYBENZYL (6R,7R)-3-CHLOROMETHYL-8-OXO-7-PHENYLACETAMIDO-5-THIA-L-AZABICYCLO [4.2.0]OCT-2-ENE-2-CARBOXYLATE GCLE CHEMICAL SUBSTANCE |
25240 | I | II | 9/19/2011 | OTSUKA AMERICA PHARMACEUTICAL INC | STERILE WATER FOR INJECTION USP, 2 ML VIAL |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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