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CYLERT

NDA

PEMOLINE | N016832 | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV

3 strengths0 unique patents0 unique exclusivities

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

API Supply Chain1 active DMF5 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

KATWIJK CHEMIE BVPEMOLINE

DMF 117801995

HOECHST CELANESE CORPInactivePEMOLINE

DMF 122381996

ORGAMOL SAInactivePEMOLINE

DMF 127961997

PLIVA DDInactivePEMOLINE

DMF 139191998

MALLINCKRODT INCInactivePEMOLINE MALLINCKRODT CODE 1500

DMF 138651998

INNOVATIVE PHARMACY SOLUTIONS LLCInactivePEMOLINE 18.75 MG COMPOUNDED CAPSULES

DMF 312682016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 25, 2003	SUPPL -22	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 18.75MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 37.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — 75MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982