FDA Orange Book · active-ingredient family
Guaifenesin
Guaifenesin is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MUCINEX · NDA 021282
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MUCINEXRLD×2 | RB HLTH | NDA 021282 | — | Dec 18, 2002 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GUAIFENESIN×2 | MARKSANS PHARMA | ANDA 217780 | — | Aug 21, 2023 | |
| GUAIFENESIN×2 | DR REDDYS | ANDA 215932 | — | Mar 15, 2022 | |
| GUAIFENESIN×2 | PERRIGO R AND D | ANDA 078912 | — | Nov 05, 2020 | |
| GUAIFENESIN×2 | GRANULES | ANDA 213420 | — | May 08, 2020 | |
| GUAIFENESIN×2 | AUROBINDO PHARMA | ANDA 210453 | — | Oct 21, 2019 | |
| GUAIFENESIN×2 | OHM LABS INC | ANDA 209254 | — | Jul 16, 2018 | |
| GUAIFENESIN×2 | AMNEAL PHARMS | ANDA 207342 | — | Jul 11, 2018 | |
| GUAIFENESIN×2 | GUARDIAN DRUG | ANDA 209215 | — | Sep 06, 2017 | |
| GUAIFENESIN | ACTAVIS LABS FL | ANDA 091009 | — | Sep 03, 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 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
