Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203484
Company: LARKEN LABS INC

Products on ANDA 203484

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALLZITAL	ACETAMINOPHEN; BUTALBITAL	325MG;25MG	TABLET;ORAL	Prescription	AA	No	Yes
BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	325MG;50MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203484

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/04/2015	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 203484

ALLZITAL

TABLET;ORAL; 325MG;25MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALLZITAL	ACETAMINOPHEN; BUTALBITAL	325MG;25MG	TABLET;ORAL	Prescription	No	AA	203484	LARKEN LABS INC
BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	325MG;25MG	TABLET;ORAL	Prescription	No	AA	214088	SENORES PHARMS

BUTALBITAL AND ACETAMINOPHEN

TABLET;ORAL; 325MG;50MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	325MG;50MG	TABLET;ORAL	Prescription	No	AA	203484	LARKEN LABS INC
BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	325MG;50MG	TABLET;ORAL	Prescription	No	AA	214291	QUAGEN
BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	325MG;50MG	TABLET;ORAL	Prescription	No	AA	214088	SENORES PHARMS
BUTAPAP	ACETAMINOPHEN; BUTALBITAL	325MG;50MG	TABLET;ORAL	Prescription	No	AA	089987	MIKART