Drug Master Files for: Bh
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Bh Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10011 | I | II | 12/14/1992 | HEUMANN PHARMA GMBH AND CO | TRIMETREXATE BASE |
10035 | A | II | 1/11/1993 | CU CHEMIE UETIKON GMBH | TERAZOSIN HYDROCHLORIDE |
1004 | I | 10/21/1966 | TROPONWERKE GMBH CO KG | METHAQUALONE BASE AND HCL | |
10099 | A | IV | 2/1/1993 | DAIKIN REFRIGERANTS EUROPE GMBH | 1,1,1,2,3,3,3-HEPTAFLUOROPROPANE (R-227) PROPELLANT GAS |
10205 | I | III | 4/15/1993 | MAUSER WERKE GMBH | PACKAGING MATERIAL |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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