Drug Master Files for: NAPHAZOLINE HYDROCHLORIDE
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NAPHAZOLINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10667 | A | II | 1/12/1994 | LOBA FEINCHEMIE GMBH | NAPHAZOLINE HYDROCHLORIDE |
| 11066 | I | II | 9/2/1994 | JOHNSON MATTHEY INC | NAPHAZOLINE HYDROCHLORIDE |
| 23642 | I | II | 3/12/2010 | ALP PHARM BEIJING CO LTD | NAPHAZOLINE HYDROCHLORIDE (DRUG SUBSTANCE, NON-STERILE) |
| 23643 | I | II | 3/12/2010 | ALP PHARM BEIJING CO LTD | NAPHAZOLINE NITRATE (DRUG SUBSTANCE, NON-STERILE) |
| 32465 | A | II | 1/30/2018 | MICRO LABS LTD | NAPHAZOLINE HYDROCHLORIDE USP |
| 32793 | A | II | 4/16/2018 | RANK ORGANICS CHEMICAL PVT LTD | NAPHAZOLINE HCL USP |
| 9709 | I | II | 6/4/1992 | CIBA GEIGY CORP PHARMACEUTICAL DIV | NAPHAZOLINE HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
