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Last Updated: April 1, 2026

Details for New Drug Application (NDA): 213536


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NDA 213536 describes REZIPRES, which is a drug marketed by Dr Reddys Labs Sa and is included in one NDA. Additional details are available on the REZIPRES profile page.

The generic ingredient in REZIPRES is ephedrine hydrochloride. There are sixty-eight drug master file entries for this compound. Additional details are available on the ephedrine hydrochloride profile page.
Summary for 213536
Tradename:REZIPRES
Applicant:Dr Reddys Labs Sa
Ingredient:ephedrine hydrochloride
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength23.5MG/5ML (4.7MG/ML)
Approval Date:Jun 14, 2021TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength47MG/ML (47MG/ML)
Approval Date:Jun 14, 2021TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength47MG/5ML (9.4MG/ML)
Approval Date:Jun 14, 2021TE:RLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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