Orange Book product · Brand (NDA)
MUCINEX
GUAIFENESIN
At a glance
Dec 18, 2002
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 18, 2002
23 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
GUAIFENESIN
Strength
1.2GM
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 021282
Product number
002
Marketing status
OTC
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2023GUAIFENESINGeneric (ANDA)
ANDA 217780 · MARKSANS PHARMA
- 2022GUAIFENESINGeneric (ANDA)
ANDA 215932 · DR REDDYS
- 2020GUAIFENESINGeneric (ANDA)
ANDA 078912 · PERRIGO R AND D
- 2020GUAIFENESINGeneric (ANDA)
ANDA 213420 · GRANULES
- 2019GUAIFENESINGeneric (ANDA)
ANDA 210453 · AUROBINDO PHARMA
- 2018GUAIFENESINGeneric (ANDA)
ANDA 209254 · OHM LABS INC
- 2018GUAIFENESINGeneric (ANDA)
ANDA 207342 · AMNEAL PHARMS
- 2017GUAIFENESINGeneric (ANDA)
ANDA 209215 · GUARDIAN DRUG
- 2015GUAIFENESINGeneric (ANDA)
ANDA 091009 · 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.
