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REZIPRES

NDA

EPHEDRINE HYDROCHLORIDE | N213536 | DR REDDYS LABORATORIES SA

4 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 Chain0 active DMFs5 inactive

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

GANES CHEMICALS INC PENNSVILLE DIVInactiveEPHEDRINE HYDROCHLORIDE

DMF 61931986

MALLADI DRUGS AND PHARMACEUTICALS LTDInactiveEPHEDRINE HYDROCHLORIDE

DMF 88041990

EMBIO LTDInactiveEPHEDRINE HYDROCHLORIDE USP

DMF 92781991

AVON ORGANICS LTDInactiveEPHEDRINE HYDROCHLORIDE USP

DMF 166192003

CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CO LTDInactiveEPHEDRINE HYDROCHLORIDE

DMF 178172004

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 15, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 23.5MG/5ML (4.7MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jun 14, 2021

No patent or exclusivity listings for this strength.

#002 — 47MG/ML (47MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jun 14, 2021

#003 — 47MG/5ML (9.4MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jun 14, 2021

#004 — 47MG/10ML (4.7MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Dec 7, 2023