Drug Master Files for: Hetero Labs Ltd
✉ Email this page to a colleague
Hetero Labs Ltd Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 17507 | A | II | 7/2/2004 | HETERO LABS LTD | IRBESARTAN (FORM A) PROCESS I |
| 17738 | A | II | 10/7/2004 | HETERO LABS LTD | LEVETIRACETAM (FORM 1) |
| 17782 | A | II | 10/26/2004 | HETERO LABS LTD | NEVIRAPINE |
| 17960 | A | II | 12/29/2004 | HETERO LABS LTD | ESCITALOPRAM OXALATE (PROCESS-I) |
| 17987 | A | II | 1/12/2005 | HETERO LABS LTD | TERBINAFINE HYDROCHLORIDE |
| 17997 | A | II | 1/17/2005 | HETERO LABS LTD | STAVUDINE |
| 18252 | A | II | 4/7/2005 | HETERO LABS LTD | LAMIVUDINE USP (PROCESS I) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
