Orange Book product · Generic (ANDA)
ACETYLCYSTEINE
ACETYLCYSTEINE
At a glance
Jul 28, 1995
Approved
Generic (ANDA)
Application
AN
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 28, 1995
31 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETYLCYSTEINE
Strength
10%
Dosage form
SOLUTION
Route
INHALATION, ORAL
TE code
AN
Application
ANDA 072489
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of ACETYLCYSTEINE
- 2016CETYLEVBrand (NDA)
NDA 207916 · ARBOR PHARMS LLC
- 2004ACETADOTEBrand (NDA)
NDA 021539 · CUMBERLAND PHARMS
- —MUCOMYSTBrand (NDA)
NDA 013601 · APOTHECON
- 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
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.
