Orange Book product · Generic (ANDA)
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
At a glance
Aug 01, 2023
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 01, 2023
2 yr 11 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
ANDA 217340
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- 2004MUCINEX DMBrand (NDA)
NDA 021620 · RB HLTH
- 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.
