Application 208175

Type
ANDA
Sponsor
DR REDDYS LABS SA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEPHENTERMINE HYDROCHLORIDE; TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALEQ 3.75MG BASE;23MGNoNo
002PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEPHENTERMINE HYDROCHLORIDE; TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALEQ 7.5MG BASE;46MGNoNo
003PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEPHENTERMINE HYDROCHLORIDE; TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALEQ 11.25MG BASE;69MGNoNo
004PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEPHENTERMINE HYDROCHLORIDE; TOPIRAMATECAPSULE, EXTENDED RELEASE;ORALEQ 15MG BASE;92MGNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82578ORIG 2025-06-16