Drug Master Files for: tamsulosin hydrochloride
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tamsulosin hydrochloride Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11761 | I | II | 12/1/1995 | ASTELLAS PHARMA INC | TAMSULOSIN HYDROCHLORIDE |
13878 | I | II | 12/3/1998 | ASTELLAS IRELAND CO LTD | TAMSULOSIN HYDROCHLORIDE |
17247 | I | II | 3/19/2004 | DR REDDYS LABORATORIES LTD | TAMSULOSIN HYDROCHLORIDE |
17318 | A | II | 4/9/2004 | LEK PHARMACEUTICALS DD | TAMSULOSIN HYDROCHLORIDE |
17688 | A | II | 9/17/2004 | CADILA HEALTHCARE LTD | TAMSULOSIN HYDROCHLORIDE USP |
17865 | I | II | 12/6/2004 | SUN PHARMACEUTICAL INDUSTRIES LTD | TAMSULOSIN HYDROCHLORIDE USP |
18067 | I | II | 1/22/2005 | TAI HENG INDUSTRY CO LTD | TAMSULOSIN HYDROCHLORIDE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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