Orange Book product · Brand (NDA)
ACETAMINOPHEN
ACETAMINOPHEN
At a glance
Feb 18, 2021
Approved
Brand (NDA)
Application
AP2
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 18, 2021
5 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN
Strength
1GM/100ML (10MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP2
Application
NDA 204957
Product number
002
Marketing status
RX
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.
- 2022ACETAMINOPHENBrand (NDA)
NDA 206968 · HIKMA
- 2021ACETAMINOPHENBrand (NDA)
NDA 206610 · RISING
- 2015ACETAMINOPHENBrand (NDA)
NDA 204767 · FRESENIUS KABI USA
- 2010OFIRMEVBrand (NDA)
NDA 022450 · MALLINCKRODT HOSP
- 1994TYLENOLBrand (NDA)
NDA 019872 · KENVUE BRANDS
- 1986INJECTAPAPBrand (NDA)
NDA 017785 · ORTHO MCNEIL PHARM
- 1983ACETAMINOPHENBrand (NDA)
NDA 018337 · TARO
- —ACEPHENBrand (NDA)
NDA 018060 · COSETTE
- —NEOPAPBrand (NDA)
NDA 016401 · POLYMEDICA
- —TYLENOLBrand (NDA)
NDA 017756 · J AND J CONSUMER INC
- 2025ACETAMINOPHENGeneric (ANDA)
ANDA 219096 · CAPLIN
- 2025ACETAMINOPHENGeneric (ANDA)
ANDA 219215 · GLAND
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.
