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HUMULIN N (INSULIN SUSP ISOPHANE RECOMBINANT HUMAN) | LOERadar

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HUMULIN N

BLA

INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | B018781 | LILLY

Biologic LOENo LOE data

No exclusivity dates or listed patents found in Purple Book

Purple Book Patents

No listed patents in Purple Book.

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

28 letters from Drugs@FDA

Date	Submission	Document
Jun 28, 2022	SUPPL -193	View Letter (PDF)
Mar 23, 2020	SUPPL -57	View Letter (PDF)
Mar 23, 2020	SUPPL -60	View Letter (PDF)
Mar 23, 2020	SUPPL -79	View Letter (PDF)
Mar 23, 2020	SUPPL -57	View Letter (PDF)
Mar 23, 2020	SUPPL -72	View Letter (PDF)
Mar 23, 2020	SUPPL -74	View Letter (PDF)
Mar 23, 2020	SUPPL -76	View Letter (PDF)
Mar 23, 2020	SUPPL -89	View Letter (PDF)
Mar 23, 2020	SUPPL -108	View Letter (PDF)
Mar 23, 2020	SUPPL -122	View Letter (PDF)
Mar 23, 2020	SUPPL -154	View Letter (PDF)
Mar 23, 2020	SUPPL -156	View Letter (PDF)
Mar 23, 2020	SUPPL -70	View Letter (PDF)
Mar 23, 2020	SUPPL -54	View Letter (PDF)
Mar 23, 2020	SUPPL -144	View Letter (PDF)
Mar 23, 2020	SUPPL -145	View Letter (PDF)
Mar 23, 2020	SUPPL -80	View Letter (PDF)
Mar 23, 2020	SUPPL -85	View Letter (PDF)
Mar 23, 2020	SUPPL -114	View Letter (PDF)
Mar 23, 2020	SUPPL -118	View Letter (PDF)
Mar 23, 2020	SUPPL -121	View Letter (PDF)
Mar 23, 2020	SUPPL -167	View Letter (PDF)
Mar 23, 2020	SUPPL -181	View Letter (PDF)
Mar 23, 2020	SUPPL -184	View Letter (PDF)
Mar 23, 2020	SUPPL -188	View Letter (PDF)
Mar 23, 2020	SUPPL -187	View Letter (PDF)
Mar 23, 2020	SUPPL -88	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100 UNITS/ML

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INJECTABLE;INJECTION | Approved: 1982-10-28 00:00:00

No patent or exclusivity listings for this strength.