Orange Book product · Generic (ANDA)
ACETAMINOPHEN
ACETAMINOPHEN
At a glance
Aug 25, 2021
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 25, 2021
4 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN
Strength
650MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 215486
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ACETAMINOPHEN
- 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
- 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
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.
