Drug Master Files for: Hospira Inc
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Hospira Inc Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10012 | I | II | 12/16/1992 | HOSPIRA INC | SPC-100270 EMULSION |
11365 | I | II | 2/23/1995 | HOSPIRA INC | CLEVIDIPINE EMULSION |
11427 | A | III | 3/28/1995 | HOSPIRA INC | PC-79 HEAT SEAL ADHESIVE |
12832 | I | II | 1/29/1998 | HOSPIRA INC | LAMISIL EMULSION |
13258 | I | III | 9/30/1998 | HOSPIRA INC | ALUER VIAL SUBASSEMBLY |
13709 | A | II | 9/1/1998 | HOSPIRA INC A PFIZER CO | VANCOMYCIN HYDROCHLORIDE |
13905 | I | II | 12/21/1998 | HOSPIRA INC | TEQUIN I.V. (GATIFLOXACIN) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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