➤ Get the DrugPatentWatch Daily Briefing

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

Serving leading biopharmaceutical companies globally:

Merck
Colorcon
Dow
Mallinckrodt
Johnson and Johnson
McKesson

Last Updated: February 26, 2021

DrugPatentWatch Database Preview

Drug Master Files for: dexmethylphenidate

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard


dexmethylphenidate Drug Master Files

DMF No. Status Type Submission Date Holder Subject
13228 A II 9/21/1998 SIEGFRIED USA LLC DEXMETHYLPHENIDATE HYDROCHLORIDE
17117 A II 1/23/2004 LONZA INC DEXMETHYLPHENIDATE HYDROCHLORIDE (DMP.HCL)
20385 A II 3/28/2007 EUTICALS INC DEXMETHYLPHENIDATE HYDROCHLORIDE
29784 A II 10/7/2015 AMPAC FINE CHEMICALS LLC DEXMETHYLPHENIDATE HCl API
30657 A II 10/7/2016 SPECGX LLC DEXMETHYLPHENIDATE HYDROCHLORIDE
32902 A II 6/23/2018 ALKEM LABORATORIES LTD DEXMETHYLPHENIDATE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
Moodys
Express Scripts
Johnson and Johnson
Merck
Baxter

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.