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HUMULIN 70/30 (INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN) | LOERadar

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HUMULIN 70/30

BLA

INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | B019717 | 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

26 letters from Drugs@FDA

Date	Submission	Document
Jun 28, 2022	SUPPL -174	View Letter (PDF)
Mar 23, 2020	SUPPL -68	View Letter (PDF)
Mar 23, 2020	SUPPL -87	View Letter (PDF)
Mar 23, 2020	SUPPL -124	View Letter (PDF)
Mar 23, 2020	SUPPL -32	View Letter (PDF)
Mar 23, 2020	SUPPL -41	View Letter (PDF)
Mar 23, 2020	SUPPL -50	View Letter (PDF)
Mar 23, 2020	SUPPL -52	View Letter (PDF)
Mar 23, 2020	SUPPL -60	View Letter (PDF)
Mar 23, 2020	SUPPL -69	View Letter (PDF)
Mar 23, 2020	SUPPL -30	View Letter (PDF)
Mar 23, 2020	SUPPL -123	View Letter (PDF)
Mar 23, 2020	SUPPL -54	View Letter (PDF)
Mar 23, 2020	SUPPL -35	View Letter (PDF)
Mar 23, 2020	SUPPL -94	View Letter (PDF)
Mar 23, 2020	SUPPL -98	View Letter (PDF)
Mar 23, 2020	SUPPL -99	View Letter (PDF)
Mar 23, 2020	SUPPL -101	View Letter (PDF)
Mar 23, 2020	SUPPL -133	View Letter (PDF)
Mar 23, 2020	SUPPL -135	View Letter (PDF)
Mar 23, 2020	SUPPL -146	View Letter (PDF)
Mar 23, 2020	SUPPL -161	View Letter (PDF)
Mar 23, 2020	SUPPL -165	View Letter (PDF)
Mar 23, 2020	SUPPL -169	View Letter (PDF)
Mar 23, 2020	SUPPL -168	View Letter (PDF)
Mar 23, 2020	SUPPL -58	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 30 UNITS/ML;70 UNITS/ML

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INJECTABLE;INJECTION | Approved: 1989-04-25 00:00:00

No patent or exclusivity listings for this strength.

#002 — 30 UNITS/ML;70 UNITS/ML

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INJECTABLE;INJECTION | Approved: 1989-04-25 00:00:00