Drug Master Files for: phenylephrine hydrochloride
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phenylephrine hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16918 | A | II | 10/19/2003 | DIVI'S LABOTATORIES LTD | PHENYLEPHRINE HYDROCHLORIDE USP |
| 18057 | A | II | 1/24/2005 | CHENG FONG CHEMICAL CO LTD | PHENYLEPHRINE HYDROCHLORIDE |
| 18319 | A | II | 5/6/2005 | SYN-TECH CHEM AND PHARM CO LTD | PHENYLEPHRINE HYDROCHLORIDE USP |
| 18788 | A | II | 9/20/2005 | MALLADI DRUGS AND PHARMACEUTICALS LTD | PHENYLEPHRINE AND SALT |
| 18799 | I | II | 9/20/2005 | SHENZHEN ORIENTAL PHARMACEUTICAL CO LTD | PHENYLEPHRINE HYDROCHLORIDE (API) |
| 18899 | A | II | 10/21/2005 | NOVUS FINE CHEMICALS LLC | PHENYLEPHRINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
