Application 202091

Type: NDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUPRAX	CEFIXIME	FOR SUSPENSION;ORAL	500MG/5ML	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27437-207	SUPRAX	cefixime	Lupin Pharmaceuticals, Inc.	NDA	Current
27437-207	SUPRAX	cefixime	Lupin Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60755	SUPPL	2019-10-31
60727	SUPPL	2019-10-30
53567	SUPPL	2018-04-01
53527	SUPPL	2018-03-29
47596	SUPPL	2017-03-20
47579	SUPPL	2017-03-17
40114	SUPPL	2016-01-12
9956	SUPPL	2016-01-11
19057	SUPPL	2014-06-04
9955	SUPPL	2014-06-02
43382	ORIG	2014-01-08
24406	ORIG	2014-01-08
19056	ORIG	2013-02-21
9954	ORIG	2013-02-21