Drug Master Files for: CHLOROTHIAZIDE
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CHLOROTHIAZIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
1059 | I | II | 5/10/1967 | MICRO CHEMS LTD | HYDROCHLOROTHIAZIDE USP |
15991 | A | II | 5/31/2002 | DAIICHI SANKYO EUROPE GMBH | CS-866-HYDROCHLOROTHIAZIDE TABLETS (CS-866HCTZ) |
16278 | A | II | 11/26/2002 | UNICHEM LABORATORIES LTD | HYDROCHLOROTHIAZIDE USP |
16707 | A | II | 7/7/2003 | IPCA LABORATORIES LTD | HYDROCHLOROTHIAZIDE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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