Application 021585

Type: NDA
Sponsor: RB HLTH

Related Records

Company: RB HLTH

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MUCINEX D	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	600MG;60MG	Yes	No
002	MUCINEX D	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1.2GM;120MG	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0077	Guaifenesin and Pseudoephedrine Hydrochloride	Guaifenesin and Pseudoephedrine Hydrochloride	WALGREEN COMPANY	NDA	Current
0363-9930	Guaifenesin D	Guaifenesin and Pseudoephedrine Hydrochloride	Walgreen Company	NDA	Current
0363-9930	Guaifenesin D	Guaifenesin and Pseudoephedrine Hydrochloride	Walgreen Company	NDA	Current
0536-1137	Mucus Relief D	Guaifenesin and Pseudoephedrine Hydrochloride	Rugby Laboratories	NDA	Current
0536-1333	Guaifenesin D	Guaifenesin and Pseudoephedrine Hydrochloride	RUGBY LABORATORIES, INC.	NDA	Current
0536-1333	Guaifenesin D	Guaifenesin and Pseudoephedrine Hydrochloride	RUGBY LABORATORIES, INC.	NDA	Current
50090-1075	Mucinex D	Guaifenesin and Pseudoephedrine Hydrochloride	A-S Medication Solutions	NDA	Current
50090-1075	Mucinex D	Guaifenesin and Pseudoephedrine Hydrochloride	A-S Medication Solutions	NDA	Current
50090-1076	Mucinex D	Guaifenesin and Pseudoephedrine Hydrochloride	A-S Medication Solutions	NDA	Current
50090-1076	Mucinex D	Guaifenesin and Pseudoephedrine Hydrochloride	A-S Medication Solutions	NDA	Current
51660-071	Guaifenesin and Pseudoephedrine Hydrochloride	Guaifenesin and Pseudoephedrine Hydrochloride	OHM LABORATORIES INC	NDA	Current
51660-071	Guaifenesin and Pseudoephedrine Hydrochloride	Guaifenesin and Pseudoephedrine Hydrochloride	OHM LABORATORIES INC	NDA	Current
63824-041	Mucinex D	Guaifenesin and Pseudoephedrine Hydrochloride	Reckitt Benckiser LLC	NDA	Current
63824-041	Mucinex D	Guaifenesin and Pseudoephedrine Hydrochloride	RB Health (US) LLC	NDA	Current
63824-041	Mucinex D	Guaifenesin and Pseudoephedrine Hydrochloride	RB Health (US) LLC	NDA	Current
63824-057	Mucinex D	Guaifenesin and Pseudoephedrine Hydrochloride	RB Health (US) LLC	NDA	Current
63824-057	Mucinex D	Guaifenesin and Pseudoephedrine Hydrochloride	RB Health (US) LLC	NDA	Current
63824-057	Mucinex D	Guaifenesin and Pseudoephedrine Hydrochloride	RB Health (US) LLC	NDA	Current
68258-3035	Mucinex D	Guaifenesin and Pseudoephedrine Hydrochloride	Dispensing Solutions Inc.	NDA	Current
70000-0580	Guaifenesin D	Guaifenesin and Pseudoephedrine Hydrochloride	CARDINAL HEALTH 110, LLC. DBA LEADER	NDA	Current
70000-0580	Guaifenesin D	Guaifenesin and Pseudoephedrine Hydrochloride	CARDINAL HEALTH 110, LLC. DBA LEADER	NDA	Current
70518-0523	Mucinex D	Guaifenesin and Pseudoephedrine Hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-0523	Mucinex D	Guaifenesin and Pseudoephedrine Hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-0523	Mucinex D	Guaifenesin and Pseudoephedrine Hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-0523	Mucinex D	Guaifenesin and Pseudoephedrine Hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-0523	Mucinex D	Guaifenesin and Pseudoephedrine Hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-0523	Mucinex D	Guaifenesin and Pseudoephedrine Hydrochloride	REMEDYREPACK INC.	NDA	Current

Documents

Document	Submission type	Date
78999	SUPPL	2024-07-09
78998	SUPPL	2024-07-09
60166	SUPPL	2019-10-01
50586	SUPPL	2017-12-04
50583	SUPPL	2017-12-01
28181	SUPPL	2014-03-07
28180	SUPPL	2010-12-22
37277	SUPPL	2007-09-07
28179	SUPPL	2007-09-07
21744	ORIG	2005-12-01
28178	SUPPL	2005-03-03
5783	SUPPL	2005-01-26
37276	ORIG	2004-06-25
28177	ORIG	2004-06-25