Drug Master Files for: Valeant
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Valeant Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10513 | A | II | 10/5/1993 | VALEANT PHARMACEUTICALS NORTH AMERICA LLC | PIRBUTEROL ACETATE |
13151 | I | II | 8/24/1998 | VALEANT PHARMACEUTICALS NORTH AMERICA | MOGADON (NITRAZEPAM) TABLETS |
18994 | A | II | 12/2/2005 | VALEANT PHARMACEUTICALS NORTH AMERICA LLC | METFORMIN AQ 1000 MG EXTENDED RELEASE TABLETS |
24013 | A | II | 7/30/2010 | ATON PHARMA A DIVISION OF VALEANT PHARMACEUTICALS NORTH AMERICA LLC | PENICILLAMINE |
5505 | A | II | 7/16/1984 | VALEANT PHARMACEUTICALS NORTH AMERICA | PYRIDOSTIGMINE BROMIDE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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