Application 077858

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	TABLET;ORAL	325MG;37.5MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-8088	Tramadol Hydrochloride and Acetaminophen	tramadol hydrochloride and acetaminophen	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8088	Tramadol Hydrochloride and Acetaminophen	tramadol hydrochloride and acetaminophen	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8088	Tramadol Hydrochloride and Acetaminophen	tramadol hydrochloride and acetaminophen	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8088	Tramadol Hydrochloride and Acetaminophen	tramadol hydrochloride and acetaminophen	Mylan Pharmaceuticals Inc.	ANDA	Current
68788-7652	Tramadol Hydrochloride and Acetaminophen	tramadol hydrochloride and acetaminophen	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9267	Tramadol Hydrochloride and Acetaminophen	tramadol hydrochloride and acetaminophen	Preferred Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76123	ORIG	2023-11-03
9091	ORIG	2008-10-01