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PENTAMIDINE ISETHIONATE

ANDA

PENTAMIDINE ISETHIONATE | A206667 | PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC AND DBA PAI PHARMA

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: NEBUPENT(TE code: AN)

API Supply Chain2 active DMFs11 inactive

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

DELMAR CHEMICALS INCPENTAMIDINE ISETHIONATE

DMF 64921986

EMCURE PHARMACEUTICALS LTDPENTAMIDINE ISETHIONATE USP

DMF 339382019

RHODIA INCInactivePENTAMIDINE ISETHIONATE

DMF 9751966

ALDRICH CHEMICAL CO INCInactivePENTAMIDINE ISETHIONATE (PRODUCT W149-5)

DMF 52801984

RHONE POULENC RORER INCInactivePENTAMIDINE ISETHIONATE

DMF 62881985

PHARM ECO LABORATORIES INCInactivePENTAMIDINE ISETHIONATE

DMF 81721989

OMNICHEM NVInactivePENTAMIDINE ISETHIONATE

DMF 79611989

NATIONAL CANCER INSTITUTEInactivePENTAMIDINE ISETHIONATE

DMF 80091989

ABBOTT LABORATORIESInactivePENTAMIDINE ISETHIONATE

DMF 81761989

ROUSSEL LABORATORIES LTDInactivePENTAMIDINE ISETHIONATE

DMF 90591991

NEWPORT PHARMACEUTICALS IRELANDInactivePENTAMIDINE ISETHIONATE

DMF 96251992

SIPSY CHIMIE FINE SCAInactivePENTAMIDINE ISETHIONATE

DMF 103161993

RELIABLE BIOPHARMACEUTICAL LLCInactivePENTAMIDINE ISETHIONATE USP

DMF 316362017

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 22, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 300MG/VIAL

0 patents0 exclusivities▴

FOR SOLUTION;INHALATION | Approved: Apr 24, 2019

No patent or exclusivity listings for this strength.