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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214291
Company: QUAGEN

Products on ANDA 214291

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214291

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/18/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214291

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

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