Application 761201

Type: BLA
Sponsor: MYLAN PHARMS INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761201	Semglee	insulin glargine-yfgn	351(k) Interchangeable	Rx	2026-07-01

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEMGLEE	INSULIN GLARGINE-YFGN	INJECTABLE;INJECTION	10ML(100UNITS/ML)	No	No
002	SEMGLEE	INSULIN GLARGINE-YFGN	INJECTABLE;INJECTION	3ML(100UNITS/ML)	No	No

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Insulin Glargine	INSULIN GLARGINE-YFGN	Biocon Biologics Inc.	3ac85ebb-5594-59c8-77fd-df254329d151	2026-01-23	Warnings, Adverse reactions	Exact identifier application number: BLA761201
INSULIN GLARGINE	INSULIN GLARGINE-YFGN	Civica, Inc.	72cfe377-52f6-0348-fc71-5d4ac1992ffb	2025-07-24	Warnings, Adverse reactions	Exact identifier application number: BLA761201
INSULIN GLARGINE	INSULIN GLARGINE-YFGN	Civica, Inc.	216f2167-c201-76fe-81ed-0d51fe53832f	2025-07-03	Warnings, Adverse reactions	Exact identifier application number: BLA761201
SEMGLEE	INSULIN GLARGINE-YFGN	Biocon Biologics Inc.	8cf5544f-87d6-468b-f6ae-898b1fdb5d80	2025-03-03	Warnings, Adverse reactions	Exact identifier application number: BLA761201

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49502-250	SEMGLEE	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-250	SEMGLEE	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-250	SEMGLEE	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-250	SEMGLEE	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-251	SEMGLEE	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-251	SEMGLEE	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-251	SEMGLEE	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-251	SEMGLEE	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-393	Insulin Glargine	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-393	Insulin Glargine	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-393	Insulin Glargine	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-394	Insulin Glargine	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-394	Insulin Glargine	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-394	Insulin Glargine	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80430	SUPPL	2024-11-26
80419	SUPPL	2024-11-26
76704	SUPPL	2023-11-30
76700	SUPPL	2023-11-30
74412	SUPPL	2023-05-31
74410	SUPPL	2023-05-31
68528	ORIG	2021-09-02
68218	ORIG	2021-07-29
68217	ORIG	2021-07-28