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ZENPEP (PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)) | LOERadar

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ZENPEP

BLA

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | B022210 | EURAND PHARMA LTD

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

8 letters from Drugs@FDA

Date	Submission	Document
Feb 29, 2024	SUPPL -26	View Letter (PDF)
Oct 30, 2023	SUPPL -27	View Letter (PDF)
Dec 7, 2022	SUPPL -24	View Letter (PDF)
Mar 23, 2020	SUPPL -8	View Letter (PDF)
Mar 23, 2020	ORIG -1	View Letter (PDF)
Mar 23, 2020	SUPPL -12	View Letter (PDF)
Mar 23, 2020	SUPPL -9	View Letter (PDF)
Mar 23, 2020	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (8)

Sort:

#001 — 24,000USP UNITS;5,000USP UNITS;17,000USP UNITS

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CAPSULE, DELAYED RELEASE;ORAL | Approved: 2009-08-27 00:00:00

No patent or exclusivity listings for this strength.

#002 — 42,000USP UNITS;10,000USP UNITS;32,000USP UNITS

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CAPSULE, DELAYED RELEASE;ORAL | Approved: 2009-08-27 00:00:00

#003 — 63,000USP UNITS;15,000USP UNITS;47,000USP UNITS

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CAPSULE, DELAYED RELEASE;ORAL | Approved: 2009-08-27 00:00:00

#004 — 84,000USP UNITS;20,000USP UNITS;63,000USP UNITS

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CAPSULE, DELAYED RELEASE;ORAL | Approved: 2009-08-27 00:00:00

#005 — 14,000USP UNITS;3,000USP UNITS;10,000USP UNITS

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CAPSULE, DELAYED RELEASE;ORAL | Approved: 2009-08-27 00:00:00

#006 — 105,000USP UNITS;25,000USP UNITS;79,000USP UNITS

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CAPSULE, DELAYED RELEASE;ORAL | Approved: 2009-08-27 00:00:00

#007 — 168,000USP UNITS;40,000USP UNITS;126,000USP UNITS

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CAPSULE, DELAYED RELEASE;ORAL | Approved: 2009-08-27 00:00:00

#008 — 252,600USP UNITS;60,000USP UNITS;189,600USP UNITS

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CAPSULE, DELAYED RELEASE;ORAL | Approved: 2009-08-27 00:00:00