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EXTRA-STRENGTH AIM

NDA

SODIUM MONOFLUOROPHOSPHATE | N019518 | CHESEBROUGH PONDS INC

2 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 Chain2 active DMFs2 inactive

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

TIANJIN YAGUANG HIGH TECH DEVELOPMENT COSODIUM MONOFLUOROPHOSPHATE

DMF 228942009

WENDENG JINYE INDUSTRIAL CO LTDSODIUM MONOFLUOROPHOSPHATE

DMF 333542018

OZARK MAHONING COInactiveSODIUM MONOFLUOROPHOSPHATE

DMF 5451963

FOREST LABORATORIES INCInactiveSODIUM MONOFLUOROPHOSPHATE 76 MG. C.R. TABLETS

DMF 71191987

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

Products (2)

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#001 — 1.2%

0 patents0 exclusivities▴

PASTE;DENTAL | Approved: Jun 3, 1987

No patent or exclusivity listings for this strength.

#002 — 1.2%

0 patents0 exclusivities▾

GEL;DENTAL | Approved: Aug 6, 1986