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Drug Master Files for: AMANTADINE HYDROCHLORIDE
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AMANTADINE HYDROCHLORIDE Drug Master Files
||ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LTD
||AMANTADINE HYDROCHLORIDE USP
||CILAG CHEMIE AG
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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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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