Drug Master Files for: Granules India
✉ Email this page to a colleague
Granules India Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11436 | I | II | 4/5/1995 | GRANULES INDIA LTD | COMPRESSO-90-P (ACETAMINOPHEN GRANULES 90%) |
11513 | I | II | 5/11/1995 | GRANULES INDIA LTD | COMPRESSO-90-CP(F) (ACETAMINOPHEN GRANULES 90%) |
14370 | I | II | 8/30/1999 | GRANULES INDIA LTD | COMPRESSO GGF 95P |
14371 | I | II | 8/30/1999 | GRANULES INDIA LTD | COMPRESSO GGF95 |
14372 | A | II | 8/30/1999 | GRANULES INDIA LTD | GUAIFENESIN USP |
15809 | I | II | 1/10/2002 | GRANULES INDIA LTD | COMPRESSO PAP 90CPC |
15810 | I | II | 1/10/2002 | GRANULES INDIA LTD | COMPRESSO PAP 90CPF |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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