➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Moodys
Dow
McKinsey
Medtronic
Colorcon
Mallinckrodt

Last Updated: August 5, 2020

DrugPatentWatch Database Preview

Drug Master Files for: AMITRIPTYLINE HYDROCHLORIDE

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard


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
19635 A II 7/28/2006 VASUDHA PHARMA CHEM LTD AMITRIPTYLINE HYDROCHLORIDE USP
2413 I II 3/10/1975 KV PHARMACEUTICAL CO AMITRIPTYLINE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Dow
McKesson
Boehringer Ingelheim
Johnson and Johnson
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.