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PHENYLEPHRINE HYDROCHLORIDE

NDA

PHENYLEPHRINE HYDROCHLORIDE | N207926 | ALCON RESEARCH LLC

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 Chain9 active DMFs5 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

DIVI'S LABOTATORIES LTDPHENYLEPHRINE HYDROCHLORIDE USP

DMF 169182003

CHENG FONG CHEMICAL CO LTDPHENYLEPHRINE HYDROCHLORIDE

DMF 180572005

SYN-TECH CHEM AND PHARM CO LTDPHENYLEPHRINE HYDROCHLORIDE USP

DMF 183192005

NOVUS FINE CHEMICALS LLCPHENYLEPHRINE HYDROCHLORIDE

DMF 188992005

SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBHPHENYLEPHRINE HYDROCHLORIDE

DMF 230832009

TRANSO PHARM HANDELS GMBHPHENYLEPHRINE HYDROCHLORIDE

DMF 287542014

UNICHEM LABORATORIES LTDPHENYLEPHRINE HYDROCHLORIDE USP

DMF 324382018

ZHEJIANG BOXIAO BIOPHARMACEUTICAL CO LTDPHENYLEPHRINE HYDROCHLORIDE

DMF 397302024

AARTI PHARMALABS LTDPHENYLEPHRINE HYDROCHLORIDE

DMF 425892025

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactivePHENYLEPHRINE HYDROCHLORIDE

DMF 59121985

SHENZHEN ORIENTAL PHARMACEUTICAL CO LTDInactivePHENYLEPHRINE HYDROCHLORIDE (API)

DMF 187992005

CAMBREX CHARLES CITY INCInactivePHENYLEPHRINE HYDROCHLORIDE

DMF 195502006

SHENZHEN HAPPY PHARMACEUTICALS LTDInactivePHENYLEPHRINE HYDROCHLORIDE

DMF 216142008

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactivePHENYLEPHRINE HYDROCHLORIDE 150 MESH

DMF 230072009

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 5, 2019	SUPPL -2	View Letter (PDF)
Jan 21, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 2.5%

RLDAT

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Jan 15, 2015

No patent or exclusivity listings for this strength.

#002 — 10%

RLDAT

0 patents0 exclusivities▾

SOLUTION/DROPS;OPHTHALMIC | Approved: Jan 15, 2015