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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206615
Company: XSPIRE PHARMA

Products on ANDA 206615

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	300MG;50MG;40MG	CAPSULE;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206615

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/04/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 206615

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

CAPSULE;ORAL; 300MG;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	300MG;50MG;40MG	CAPSULE;ORAL	Prescription	No	AA	213321	GRANULES
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	300MG;50MG;40MG	CAPSULE;ORAL	Prescription	No	AA	215135	HIKMA
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	300MG;50MG;40MG	CAPSULE;ORAL	Prescription	No	AA	212082	LANNETT CO INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	300MG;50MG;40MG	CAPSULE;ORAL	Prescription	No	AA	040885	LGM PHARMA
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	300MG;50MG;40MG	CAPSULE;ORAL	Prescription	No	AA	210817	MAYNE PHARMA INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	300MG;50MG;40MG	CAPSULE;ORAL	Prescription	No	AA	215047	NOVAST LABS
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	300MG;50MG;40MG	CAPSULE;ORAL	Prescription	No	AA	207118	NUVO PHARMS INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	300MG;50MG;40MG	CAPSULE;ORAL	Prescription	No	AA	214087	SENORES PHARMS
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	300MG;50MG;40MG	CAPSULE;ORAL	Prescription	No	AA	213046	TARO PHARM INDS LTD
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	300MG;50MG;40MG	CAPSULE;ORAL	Prescription	No	AA	206615	XSPIRE PHARMA

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