Viewing data from:

COTAZYM

BLA

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | B020580 | ORGANON USA INC

1 product0 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 20580

351(a) ReferenceVoluntarily RevokedCDERCapsule, Delayed Release

Proper Name

pancrelipase

Applicant

Organon USA Inc., a subsidiary of Merck & Co., Inc.

Approval Date

9-Dec-96

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

Products (1)

#001 — 30,000USP UNITS;8,000USP UNITS;30,000USP UNITS

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CAPSULE;ORAL | Approved: 1996-12-09 00:00:00

No patent or exclusivity listings for this strength.