FDA Orange Book · active-ingredient family
Guaifenesin; pseudoephedrine hydrochloride
Guaifenesin; pseudoephedrine hydrochloride is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MUCINEX D · NDA 021585
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MUCINEX DRLD×2 | RB HLTH | NDA 021585 | — | Jun 22, 2004 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE×2 | GRANULES | ANDA 216082 | — | Aug 22, 2022 | |
| GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE×2 | L PERRIGO CO | ANDA 214407 | — | Feb 01, 2022 | |
| GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE×2 | SUN PHARM INDS INC | ANDA 212542 | — | Apr 28, 2020 | |
| GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE×2 | AUROBINDO PHARMA LTD | ANDA 213203 | — | Mar 25, 2020 | |
| GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE×2 | DR REDDYS | ANDA 208369 | — | Dec 29, 2017 | |
| GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE×2 | ACTAVIS LABS FL | ANDA 091071 | — | May 27, 2015 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Guaifenesin; pseudoephedrine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
