Orange Book product · Brand (NDA)
MUCINEX DM
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
At a glance
Apr 29, 2004
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 29, 2004
22 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Strength
30MG;600MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 021620
Product number
002
Marketing status
OTC
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2023GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 217340 · DR REDDYS
- 2021GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 214781 · SUN PHARM
- 2018GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 209692 · AMNEAL PHARMS
- 2018GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 207602 · PERRIGO R AND D
- 2017GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 206941 · AUROBINDO PHARMA
- 2015GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 091070 · ACTAVIS LABS FL
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.
