Application 040331

Type: ANDA
Sponsor: EPIC PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	Yes
002	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	TABLET;ORAL	100MG	No	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42806-050	Meperidine Hydrochloride	Meperidine Hydrochloride	EPIC PHARMA, LLC	ANDA	Current
42806-050	Meperidine Hydrochloride	Meperidine Hydrochloride	EPIC PHARMA, LLC	ANDA	Current
42806-050	Meperidine Hydrochloride	Meperidine Hydrochloride	EPIC PHARMA, LLC	ANDA	Current
42806-051	Meperidine Hydrochloride	Meperidine Hydrochloride	EPIC PHARMA, LLC	ANDA	Current
42806-051	Meperidine Hydrochloride	Meperidine Hydrochloride	EPIC PHARMA, LLC	ANDA	Current
42806-051	Meperidine Hydrochloride	Meperidine Hydrochloride	EPIC PHARMA, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76297	ORIG	2023-11-03
7626	ORIG	1999-05-28