Orange Book product · Brand (NDA)
MUCOMYST
ACETYLCYSTEINE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
ACETYLCYSTEINE
Strength
10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
INHALATION, ORAL
TE code
Not listed
Application
NDA 013601
Product number
002
Marketing status
DISCN
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.
- 2016CETYLEVBrand (NDA)
NDA 207916 · ARBOR PHARMS LLC
- 2004ACETADOTEBrand (NDA)
NDA 021539 · CUMBERLAND PHARMS
- 2025ACETYLCYSTEINEGeneric (ANDA)
ANDA 214177 · CONBA USA
- 2025ACETYLCYSTEINEGeneric (ANDA)
ANDA 219194 · SOMERSET THERAPS LLC
- 2024ACETYLCYSTEINEGeneric (ANDA)
ANDA 218397 · SOMERSET THERAPS LLC
- 2023ACETYLCYSTEINEGeneric (ANDA)
ANDA 205643 · EXELA PHARMA
- 2023ACETYLCYSTEINEGeneric (ANDA)
ANDA 217182 · ONESOURCE SPECIALTY
- 2022ACETYLCYSTEINEGeneric (ANDA)
ANDA 215620 · REGCON HOLDINGS
- 2022ACETYLCYSTEINEGeneric (ANDA)
ANDA 213693 · GLENMARK PHARMS
- 2021ACETYLCYSTEINEGeneric (ANDA)
ANDA 204797 · EXELA PHARMA
- 2018ACETYLCYSTEINEGeneric (ANDA)
ANDA 208166 · ZYDUS PHARMS
- 2017ACETYLCYSTEINEGeneric (ANDA)
ANDA 091684 · SAGENT PHARMS INC
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.
