FDA Orange Book · active-ingredient family
Dextromethorphan hydrobromide; guaifenesin
Dextromethorphan hydrobromide; guaifenesin 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 DM · NDA 021620
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MUCINEX DMRLD×2 | RB HLTH | NDA 021620 | — | Apr 29, 2004 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE×2 | DR REDDYS | ANDA 217340 | — | Aug 01, 2023 | |
| GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE×2 | SUN PHARM | ANDA 214781 | — | Jul 01, 2021 | |
| GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE×2 | AMNEAL PHARMS | ANDA 209692 | — | Nov 01, 2018 | |
| GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE×2 | PERRIGO R AND D | ANDA 207602 | — | Mar 05, 2018 | |
| GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE×2 | AUROBINDO PHARMA | ANDA 206941 | — | Mar 17, 2017 | |
| GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE×2 | ACTAVIS LABS FL | ANDA 091070 | — | Aug 31, 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.
Dextromethorphan hydrobromide; guaifenesin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
