Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204733
Company: AUROLIFE PHARMA LLC

Products on ANDA 204733

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	CAPSULE;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204733

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/26/2018	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/04/2025	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204733

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

CAPSULE;ORAL; 325MG;50MG;40MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	CAPSULE;ORAL	Prescription	No	AA	204733	AUROLIFE PHARMA LLC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	CAPSULE;ORAL	Prescription	No	AA	089007	DR REDDYS LABS SA
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	CAPSULE;ORAL	Prescription	No	AA	212083	LANNETT CO INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	CAPSULE;ORAL	Prescription	No	AA	216376	QUAGEN
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	CAPSULE;ORAL	Prescription	No	AA	214087	SENORES PHARMS