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LEVEMIR (INSULIN DETEMIR RECOMBINANT) | LOERadar

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LEVEMIR

BLA

INSULIN DETEMIR RECOMBINANT | B021536 | NOVO NORDISK INC

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

23 letters from Drugs@FDA

Date	Submission	Document
Dec 9, 2022	SUPPL -62	View Letter (PDF)
Jul 5, 2022	SUPPL -60	View Letter (PDF)
Mar 23, 2020	SUPPL -28	View Letter (PDF)
Mar 23, 2020	SUPPL -29	View Letter (PDF)
Mar 23, 2020	SUPPL -33	View Letter (PDF)
Mar 23, 2020	SUPPL -37	View Letter (PDF)
Mar 23, 2020	SUPPL -39	View Letter (PDF)
Mar 23, 2020	SUPPL -41	View Letter (PDF)
Mar 23, 2020	SUPPL -44	View Letter (PDF)
Mar 23, 2020	SUPPL -20	View Letter (PDF)
Mar 23, 2020	SUPPL -21	View Letter (PDF)
Mar 23, 2020	ORIG -1	View Letter (PDF)
Mar 23, 2020	SUPPL -31	View Letter (PDF)
Mar 23, 2020	SUPPL -48	View Letter (PDF)
Mar 23, 2020	SUPPL -35	View Letter (PDF)
Mar 23, 2020	SUPPL -50	View Letter (PDF)
Mar 23, 2020	SUPPL -51	View Letter (PDF)
Mar 23, 2020	SUPPL -54	View Letter (PDF)
Mar 23, 2020	SUPPL -57	View Letter (PDF)
Mar 23, 2020	SUPPL -58	View Letter (PDF)
Mar 23, 2020	SUPPL -56	View Letter (PDF)
Mar 23, 2020	SUPPL -24	View Letter (PDF)
Mar 23, 2020	SUPPL -15	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 1000 UNITS/10ML (100 UNITS/ML)

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INJECTABLE;SUBCUTANEOUS | Approved: 2005-06-16 00:00:00

No patent or exclusivity listings for this strength.

#002 — 300 UNITS/3ML (100 UNITS/ML)

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INJECTABLE;SUBCUTANEOUS | Approved: 2005-06-16 00:00:00

#005 — 300 UNITS/3ML (100 UNITS/ML)

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INJECTABLE;SUBCUTANEOUS | Approved: 2005-06-16 00:00:00

#003 — 300 UNITS/3ML (100 UNITS/ML)

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INJECTABLE;SUBCUTANEOUS | Approved: 2005-06-16 00:00:00

#004 — 300 UNITS/3ML (100 UNITS/ML)

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INJECTABLE;SUBCUTANEOUS | Approved: 2005-06-16 00:00:00