Drug Master Files for: Mcneil Cons
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Mcneil Cons Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10850 | I | I | 3/31/1994 | MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC | MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ROUND ROCK, TEXAS. |
13015 | I | II | 6/10/1998 | MCNEIL CONSUMER HEALTHCARE | NICOTINE PURIFICATION PROCESS |
29236 | A | II | 7/6/2015 | JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV | NICOTINE OROMUCOSAL SPRAY |
32200 | A | II | 2/9/2018 | JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV | NICOTINE POLACRILEX LOZENGE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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