➤ Get the DrugPatentWatch Daily Briefing

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

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Express Scripts

Last Updated: August 4, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212319

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 212319 describes ATROPINE (AUTOINJECTOR), which is a drug marketed by Rafa Labs Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the ATROPINE (AUTOINJECTOR) profile page.

The generic ingredient in ATROPINE (AUTOINJECTOR) is atropine. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the atropine profile page.
Summary for 212319
Applicant:Rafa Labs Ltd
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 212319
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATROPINE (AUTOINJECTOR) atropine SOLUTION;INTRAMUSCULAR 212319 NDA Rafa Laboratories, Ltd. 71053-592 71053-592-01 480 CARTON in 1 BOX (71053-592-01) > 40 SYRINGE in 1 CARTON > .7 mL in 1 SYRINGE

Profile for product number 001

Approval Date:Jul 9, 2018TE:RLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Johnson and Johnson

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.