Drug Master Files for: LANNETT CO INC
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LANNETT CO INC Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
15940 | I | II | 4/17/2002 | CODY LABORATORIES INC A WHOLLY OWNED SUBSIDIARY OF LANNETT CO INC | PHENTERMINE HYDROCHLORIDE A INGREDIENT |
1604 | I | II | 11/24/1970 | LANNETT CO INC | MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. |
17579 | I | II | 7/29/2004 | CODY LABORATORIES INC A WHOLLY OWNED SUBSIDIARY OF LANNETT CO INC | FENTANYL CITRATE A INGREDIENT |
17916 | I | II | 12/22/2004 | CODY LABORATORIES INC A WHOLLY OWNED SUBSIDIARY OF LANNETT CO INC | FENTANYL BASE USP |
20135 | I | II | 1/11/2007 | CODY LABORATORIES INC A WHOLLY OWNED SUBSIDIARY OF LANNETT CO INC | PHENTERMINE RESIN - API |
28040 | A | II | 4/30/2014 | CODY LABORATORIES INC A WHOLLY OWNED SUBSIDIARY OF LANNETT CO INC | MORPHINE SULFATE, USP |
28041 | I | II | 6/27/2014 | CODY LABORATORIES INC A WHOLLY OWNED SUBSIDIARY OF LANNETT CO INC | HYDROCODONE BITARTRATE, USP |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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