Application 075499

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUTORPHANOL TARTRATE	BUTORPHANOL TARTRATE	SPRAY, METERED;NASAL	1MG/SPRAY	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-0813	Butorphanol Tartrate	Butorphanol Tartrate	Apotex Corp.	ANDA	Current
60505-0813	Butorphanol Tartrate	Butorphanol Tartrate	Apotex Corp.	ANDA	Current
60505-0813	Butorphanol Tartrate	Butorphanol Tartrate	Apotex Corp.	ANDA	Current
60505-0813	Butorphanol Tartrate	Butorphanol Tartrate	Apotex Corp.	ANDA	Current
60505-0813	Butorphanol Tartrate	Butorphanol Tartrate	Apotex Corp.	ANDA	Current
60505-0813	Butorphanol Tartrate	Butorphanol Tartrate	Apotex Corp.	ANDA	Current
60505-0813	Butorphanol Tartrate	Butorphanol Tartrate	Apotex Corp.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76303	ORIG	2023-11-03
22478	ORIG	2007-07-27