Application 022442

Type: NDA
Sponsor: PERSION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REZIRA	HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE	SOLUTION;ORAL	5MG/5ML;60MG/5ML	Yes	No

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54838	SUPPL	2018-07-06
54799	SUPPL	2018-07-06
54761	SUPPL	2018-07-05
46911	SUPPL	2017-01-19
46867	SUPPL	2017-01-13
24311	ORIG	2012-02-03
22022	ORIG	2012-02-03
29734	ORIG	2011-06-13
17594	ORIG	2011-06-10