Application 205509

Type: ANDA
Sponsor: ANI PHARMS INC

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
17856-1170	Morphine Sulfate	Morphine Sulfate	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-1170	Morphine Sulfate	Morphine Sulfate	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
62559-170	Morphine Sulfate	Morphine Sulfate	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-170	Morphine Sulfate	Morphine Sulfate	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-170	Morphine Sulfate	Morphine Sulfate	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-170	Morphine Sulfate	Morphine Sulfate	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-170	Morphine Sulfate	Morphine Sulfate	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-171	Morphine Sulfate	Morphine Sulfate	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-171	Morphine Sulfate	Morphine Sulfate	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-171	Morphine Sulfate	Morphine Sulfate	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-171	Morphine Sulfate	Morphine Sulfate	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-171	Morphine Sulfate	Morphine Sulfate	ANI Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76050	ORIG	2023-11-02
53766	ORIG	2018-04-20