Orange Book product · Generic (ANDA)
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
At a glance
Feb 01, 2022
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 01, 2022
4 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Strength
1.2GM;120MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 214407
Product number
002
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
- 2004MUCINEX DBrand (NDA)
NDA 021585 · RB HLTH
- 2022GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216082 · GRANULES
- 2020GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212542 · SUN PHARM INDS INC
- 2020GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213203 · AUROBINDO PHARMA LTD
- 2017GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 208369 · DR REDDYS
- 2015GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 091071 · 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.
