Drug Master Files for: AMITRIPTYLINE HYDROCHLORIDE
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AMITRIPTYLINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11027 | I | II | 7/21/1994 | MERIND LTD | AMITRIPTYLINE HYDROCHLORIDE USP |
| 18111 | A | II | 2/10/2005 | RL FINE CHEM PVT LTD | AMITRIPTYLINE HYDROCHLORIDE |
| 18174 | I | II | 3/2/2005 | WANBURY LTD | AMITRIPTYLINE |
| 19589 | A | II | 7/12/2006 | SUN PHARMACEUTICAL INDUSTRIES LTD | AMITRIPTYLINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
