Orange Book product · Generic (ANDA)
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
At a glance
Apr 07, 2014
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 07, 2014
12 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Strength
325MG;37.5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 078778
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
- 2001ULTRACETBrand (NDA)
NDA 021123 · JANSSEN PHARMS
- 2017TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENGeneric (ANDA)
ANDA 206885 · MACLEODS PHARMS LTD
- 2017TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENGeneric (ANDA)
ANDA 207152 · AUROBINDO PHARMA
- 2012TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENGeneric (ANDA)
ANDA 201952 · MICRO LABS LTD INDIA
- 2012TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENGeneric (ANDA)
ANDA 090460 · ZYDUS PHARMS USA INC
- 2012TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENGeneric (ANDA)
ANDA 202076 · ALKEM LABS LTD
- 2009TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENGeneric (ANDA)
ANDA 090485 · AMNEAL PHARMS
- 2008TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENGeneric (ANDA)
ANDA 077858 · RISING
- 2006TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENGeneric (ANDA)
ANDA 076914 · GRAVITI PHARMS
- 2005TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENGeneric (ANDA)
ANDA 077184 · SUN PHARM INDS INC
- 2005TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENGeneric (ANDA)
ANDA 076475 · CHARTWELL RX
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.
