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BLA

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT | B021172 | NOVO NORDISK INC

4 products0 Purple Book patents

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

Purple Book (Biologics)

BLA 21172 | 4 presentations

351(a) ReferenceLicensedCDERInjectable Suspension

Proper Name

insulin aspart protamine and insulin aspart

Applicant

Novo Nordisk Inc.

Approval Date

1-Nov-01

Presentations

700UNITS/10ML (70UNITS/ML); 300UNITS/10ML (30UNITS/ML) — Multi-Dose Vial (Subcutaneous)

210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML) — Autoinjector (Subcutaneous)

210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML) — Pre-Filled Syringe (Subcutaneous)

210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML) — Autoinjector (Subcutaneous)

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

25 letters from Drugs@FDA

Date	Submission	Document
Mar 1, 2023	SUPPL -76	View Letter (PDF)
Apr 29, 2021	SUPPL -74	View Letter (PDF)
Mar 23, 2020	SUPPL -13	View Letter (PDF)
Mar 23, 2020	SUPPL -51	View Letter (PDF)
Mar 23, 2020	SUPPL -63	View Letter (PDF)
Mar 23, 2020	SUPPL -64	View Letter (PDF)
Mar 23, 2020	SUPPL -38	View Letter (PDF)
Mar 23, 2020	SUPPL -39	View Letter (PDF)
Mar 23, 2020	SUPPL -43	View Letter (PDF)
Mar 23, 2020	SUPPL -44	View Letter (PDF)
Mar 23, 2020	SUPPL -45	View Letter (PDF)
Mar 23, 2020	SUPPL -3	View Letter (PDF)
Mar 23, 2020	ORIG -1	View Letter (PDF)
Mar 23, 2020	SUPPL -21	View Letter (PDF)
Mar 23, 2020	SUPPL -23	View Letter (PDF)
Mar 23, 2020	SUPPL -34	View Letter (PDF)
Mar 23, 2020	SUPPL -46	View Letter (PDF)
Mar 23, 2020	SUPPL -49	View Letter (PDF)
Mar 23, 2020	SUPPL -53	View Letter (PDF)
Mar 23, 2020	SUPPL -62	View Letter (PDF)
Mar 23, 2020	SUPPL -68	View Letter (PDF)
Mar 23, 2020	SUPPL -72	View Letter (PDF)
Mar 23, 2020	SUPPL -71	View Letter (PDF)
Mar 23, 2020	SUPPL -9	View Letter (PDF)
Mar 23, 2020	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 700 UNITS/10ML; 300 UNITS/10ML (70 UNITS/ML; 30 UNITS/ML)

▴

INJECTABLE;SUBCUTANEOUS | Approved: 2001-11-01 00:00:00

No patent or exclusivity listings for this strength.

#004 — 210 UNITS/3ML; 90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML)

▾

INJECTABLE;SUBCUTANEOUS | Approved: 2001-11-01 00:00:00

#002 — 210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML)

▾

INJECTABLE;SUBCUTANEOUS | Approved: 2001-11-01 00:00:00

#003 — 210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML)

▾

INJECTABLE;SUBCUTANEOUS | Approved: 2001-11-01 00:00:00