Drug Master Files for: Jubilant Generics
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Jubilant Generics Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
14410 | A | II | 9/21/1999 | JUBILANT GENERICS LTD | CARBAMAZEPINE USP |
15587 | A | II | 8/21/2001 | JUBILANT GENERICS LTD | CITALOPRAM HYDROBROMIDE USP |
16142 | A | II | 9/24/2002 | JUBILANT GENERICS LTD | LAMOTRIGINE USP |
16430 | A | II | 3/11/2003 | JUBILANT GENERICS LTD | OXCARBAZEPINE USP |
16517 | A | II | 4/8/2003 | JUBILANT GENERICS LTD | RISPERIDONE-USP |
18755 | A | II | 9/13/2005 | JUBILANT GENERICS LTD | SIMVASTATIN USP |
18803 | A | II | 9/27/2005 | JUBILANT GENERICS LTD | TRAMADOL HYDROCHLORIDE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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