Drug Master Files for: ISOTRETINOIN
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ISOTRETINOIN Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 13071 | I | II | 7/1/1998 | BASF AKTIENGESELLSCHAFT | 9-Z-ISOTRETINOIN |
| 14493 | I | II | 10/14/1999 | RP SCHERER NORTH AMERICA | ACCUTANE (ISOTRETINOIN) |
| 15169 | I | II | 11/29/2000 | SUN PHARMACEUTICAL INDUSTRIES LTD | ISOTRETINOIN USP (NON-STERILE BULK) |
| 19191 | A | II | 10/25/2005 | JIANGXI HENGXIANG PHARMCEUTICAL TECHNOLOGY CO LTD | ISOTRETINOIN (NON-STERILE BULK FORM) |
| 19918 | A | II | 10/30/2006 | HELSINN ADVANCED SYNTHESIS SA | ISOTRETINOIN |
| 21653 | A | II | 5/23/2008 | CHONGQING HUAPONT PHARMACEUTICAL CO LTD | ISOTRETINOIN |
| 22616 | I | II | 6/30/2009 | IPCA LABORATORIES LTD | ISOTRETINOIN 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
