Orange Book product · Generic (ANDA)
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
At a glance
Aug 27, 2003
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 27, 2003
23 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Strength
325MG;50MG;40MG
Dosage form
TABLET
Route
ORAL
TE code
AA
Application
ANDA 040511
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; CAFFEINE
- 2024BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 216376 · QUAGEN
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ANDA 214288 · QUAGEN
- 2024BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 214287 · QUAGEN
- 2022BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 215135 · HIKMA
- 2021BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 215047 · INGENUS PHARMS LLC
- 2021BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 214087 · SENORES PHARMS
- 2020BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 203647 · STRIDES PHARMA
- 2020BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 211543 · NESHER PHARMS
- 2020BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 213046 · TARO
- 2020BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 213321 · GRANULES
- 2019BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 210817 · DR REDDYS LABS SA
- 2019BUTALBITAL, ACETAMINOPHEN AND CAFFEINEGeneric (ANDA)
ANDA 212082 · LANNETT CO INC
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.
