Humulin® R / Humulin® R KwikPen® (insulin human)

BL 018780

Humulin® R / Humulin® R KwikPen® (insulin human)

BL 018780

U.S. License Holder:

Eli Lilly

Date of License:

October-28-1982

Last Update:

Oct-23-2024

approved_indications FDA-Approved Indications


HUMULIN R (insulin human) is a short-acting human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

approved_indications aBLA / 505(b)(2) Activity


aBLA / 505(b)(2) Accepted by FDA

Insulin-R: Biocon (Complete Response Letter January-2023)

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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