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PERTZYE

BLA

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | B022175 | DIGESTIVE CARE 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

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 30,250USP UNITS;8,000USP UNITS;28,750USP UNITS

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CAPSULE, DELAYED RELEASE;ORAL | Approved: 2012-05-17 00:00:00

No patent or exclusivity listings for this strength.

#002 — 60,500USP UNITS;16,000USP UNITS;57,500USP UNITS

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CAPSULE, DELAYED RELEASE;ORAL | Approved: 2012-05-17 00:00:00

#003 — 15,125USP UNITS;4,000USP UNITS;14,375USP UNITS

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CAPSULE, DELAYED RELEASE;ORAL | Approved: 2012-05-17 00:00:00

#004 — 90,750USP UNITS;24,000USP UNITS;86,250USP UNITS

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CAPSULE, DELAYED RELEASE;ORAL | Approved: 2012-05-17 00:00:00