Drug Master Files for: Catalent
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Catalent Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10319 | I | II | 6/24/1993 | CATALENT PHARMA SOLUTIONS LLC | HYTRIN (TERAZOSIN) SOFT GELATIN CAPSULES |
10499 | A | II | 9/29/1993 | CATALENT PHARMA SOLUTIONS LLC | IBUPROFEN SOFTGELS, 200 MG. |
10972 | I | II | 6/28/1994 | CATALENT PHARMA SOLUTIONS LLC | VESANOID, 10MG SOFTGELS |
11928 | I | III | 4/17/1996 | CATALENT PHARMA SOLUTIONS LLC | PACKAGING OPERATIONS IN HUMACAO, PUERTO RICO |
12327 | A | II | 1/21/1997 | CATALENT PHARMA SOLUTIONS LLC | TESSALON 100 MG AND 200 MG SOFTGEL CAPSULES AND BENZONATATE 100 MG AND 200 MG SOFTGEL CAPSULES |
12747 | I | II | 11/17/1997 | CATALENT PHARMA SOLUTIONS LLC | RITONAVIR, 100MG AND 200MG SOFT-GELATIN CAPSULE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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