Orange Book product · Brand (NDA)
ACETAMINOPHEN
ACETAMINOPHEN
At a glance
Sep 12, 1983
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 12, 1983
43 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN
Strength
120MG
Dosage form
SUPPOSITORY
Route
RECTAL
TE code
Not listed
Application
NDA 018337
Product number
003
Marketing status
OTC
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.
- 2022ACETAMINOPHENBrand (NDA)
NDA 206968 · HIKMA
- 2021ACETAMINOPHENBrand (NDA)
NDA 204957 · B BRAUN MEDICAL
- 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
- —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.
