Application 211454

Type: ANDA
Sponsor: WINDER LABS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MORPHINE SULFATE	MORPHINE SULFATE	SOLUTION;ORAL	10MG/5ML	No	No
002	MORPHINE SULFATE	MORPHINE SULFATE	SOLUTION;ORAL	20MG/5ML	No	No
003	MORPHINE SULFATE	MORPHINE SULFATE	SOLUTION;ORAL	100MG/5ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
75826-129	Morphine Sulfate	Morphine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-129	Morphine Sulfate	Morphine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-130	Morphine Sulfate	Morphine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-130	Morphine Sulfate	Morphine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-131	Morphine Sulfate	Morphine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-131	Morphine Sulfate	Morphine Sulfate	Winder Laboratories LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76468	ORIG	2023-11-07