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PHENDIMETRAZINE TARTRATE

NDA

PHENDIMETRAZINE TARTRATE | N018074 | ACERTIS PHARMACEUTICALS LLC

1 strength0 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 DMF1 inactive

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

OLON SPAPHENDIMETRAZINE TARTRATE

DMF 21401973

KV PHARMACEUTICAL COInactivePHENDIMETRAZINE TARTRATE SUSTAINED RELEASE CAPSULES 100 MG.

DMF 31351977

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 26, 2019	SUPPL -36	View Letter (PDF)
Feb 14, 2012	SUPPL -34	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 105MG

RLD

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.