Orange Book product · Generic (ANDA)
BUTALBITAL AND ACETAMINOPHEN
ACETAMINOPHEN; BUTALBITAL
At a glance
Dec 27, 2017
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 27, 2017
8 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; BUTALBITAL
Strength
300MG;50MG
Dosage form
CAPSULE
Route
ORAL
TE code
AA
Application
ANDA 207313
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of ACETAMINOPHEN; BUTALBITAL
- 2024BUTALBITAL AND ACETAMINOPHENGeneric (ANDA)
ANDA 214305 · QUAGEN
- 2024BUTALBITAL AND ACETAMINOPHENGeneric (ANDA)
ANDA 214291 · QUAGEN
- 2022BUTALBITAL AND ACETAMINOPHENGeneric (ANDA)
ANDA 214955 · NE RX PHARMA
- 2022BUTALBITAL AND ACETAMINOPHENGeneric (ANDA)
ANDA 214088 · SENORES PHARMS
- 2019BUTALBITAL AND ACETAMINOPHENGeneric (ANDA)
ANDA 213115 · GRANULES
- 2017BUTALBITAL AND ACETAMINOPHENGeneric (ANDA)
ANDA 207635 · ALVOGEN
- 2016BUTALBITAL AND ACETAMINOPHENGeneric (ANDA)
ANDA 207386 · ANDA REPOSITORY
- 2015ALLZITALGeneric (ANDA)
ANDA 203484 · PHARMOBEDIENT
- 2015BUTALBITAL AND ACETAMINOPHENGeneric (ANDA)
ANDA 205120 · ALVOGEN
- 2011BUTALBITAL AND ACETAMINOPHENGeneric (ANDA)
ANDA 090956 · LGM PHARMA
- 1992BUTAPAPGeneric (ANDA)
ANDA 089987 · MIKART
- 1992BUTAPAPGeneric (ANDA)
ANDA 089988 · MIKART
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.
