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	2026-06-01

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	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
Insulin Glargine	INSULIN GLARGINE-YFGN	Biocon Biologics Inc.	3ac85ebb-5594-59c8-77fd-df254329d151	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