Drug Master Files for: amiodarone hydrochloride
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amiodarone hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14171 | I | II | 5/28/1999 | SHANGHAI SHENLONG PHARMACEUTICAL CO LTD | AMIODARONE HYDROCHLORIDE |
| 15794 | A | II | 12/27/2001 | TARO PHARMACEUTICAL INDUSTRIES LTD | AMIODARONE HCL USP |
| 16787 | A | II | 8/27/2003 | GLENMARK PHARMACEUTICALS LTD | AMIODARONE HYDROCHLORIDE USP |
| 17217 | I | II | 3/5/2004 | AUROBINDO PHARMA LTD | AMIODARONE HYDROCHLORIDE |
| 21694 | A | II | 6/12/2008 | PIRAMAL ENTERPRISES LTD | AMIODARONE HYDROCHLORIDE |
| 24518 | I | II | 12/29/2010 | ZHEJIANG SANMEN HENGKANG PHARMACEUTICAL CO LTD | AMIODARONE HYDROCHLORIDE |
| 25892 | A | II | 4/9/2012 | CTX LIFE SCIENCES PVT LTD | AMIODARONE HYDROCHLORIDE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
