Drug Master Files for: olopatadine hydrochloride
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olopatadine hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11801 | A | II | 1/10/1996 | KYOWA HAKKO KIRIN CO LTD | OLOPATADINE HYDROCHLORIDE (KW 4679) |
| 19417 | A | II | 5/9/2006 | URQUIMA SA | OLOPATADINE HYDROCHLORIDE |
| 19526 | A | II | 6/14/2006 | CRYSTAL PHARMA SAU | OLOPATADINE HYDROCHLORIDE (PROCESS I) |
| 22430 | A | II | 1/7/2009 | CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD | OLOPATADINE HCL |
| 23240 | A | II | 10/30/2009 | FIS FABBRICA ITALIANA SINTETICI SPA | OLOPATADINE HYDROCHLORIDE |
| 23908 | A | II | 6/18/2010 | PCAS | OLOPATADINE HCL |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
